ENDOSCOPIC RESECTION (ER) OF THE OESOPHAGUS AND

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ENDOSCOPIC RESECTION (ER) OF THE OESOPHAGUS AND

GASTRO-OESOPHAGEAL JUNCTION.

STRUCTURED REPORTING PROTOCOL

(1st Edition 2013)

Core Document versions:

• AJCC Cancer Staging Manual 7th edition (including errata corrected with 5th reprint 10th Aug 2010).

• World Health Organization Classification of Tumours Pathology and Genetics of Tumours of the Digestive System, 2010, 4th edition

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ISBN: 978-1-74187-716-8

Publications number (SHPN): (CI) 120057

Online copyright

© RCPA 2013

This work (Protocol) is copyright. You may download, display, print and reproduce the Protocol for your personal, non-commercial use or use within your organisation subject to the following terms and conditions:

1. The Protocol may not be copied, reproduced, communicated or displayed, in whole or in part, for profit or commercial gain.

2. Any copy, reproduction or communication must include this RCPA copyright notice in full.

3. With the exception of Chapter 6 - the checklist, no changes may be made to the wording of the Protocol including any Standards, Guidelines, commentary, tables or diagrams. Excerpts from the Protocol may be used in support of the checklist. References and acknowledgments must be maintained in any reproduction or copy in full or part of the Protocol.

4. In regard to Chapter 6 of the Protocol - the checklist:

o The wording of the Standards may not be altered in any way and must be included as part of the checklist.

o Guidelines are optional and those which are deemed not applicable may be removed.

o Numbering of Standards and Guidelines must be retained in the checklist, but can be reduced in size, moved to the end of the checklist item or greyed out or other means to minimise the visual impact.

o Additional items for local use may be added but must not be numbered as a Standard or Guideline, in order to avoid confusion with the RCPA checklist items.

o Formatting changes in regard to font, spacing, tabulation and sequencing may be made.

o Commentary from the Protocol may be added or hyperlinked to the relevant checklist item.

Apart from any use as permitted under the Copyright Act 1968 or as set out above, all other rights are reserved. Requests and inquiries concerning reproduction and rights should be addressed to RCPA, 207 Albion St, Surry Hills, NSW 2010, Australia.

First published: February 2013, 1st Edition (Version 1.0)

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Disclaimer

The Royal College of Pathologists of Australasia ("College") has developed these protocols as an educational tool to assist pathologists in reporting of relevant information for specific cancers. While each protocol includes “standards” and “guidelines” which are indicators of ‘minimum requirements’ and ‘recommendations’, the protocols are a first edition and have not been through a full cycle of use, review and refinement. Therefore, in this edition, the inclusion of “standards” and “guidelines” in each document are provided as an indication of the opinion of the relevant expert authoring group, but should not be regarded as definitive or as widely accepted peer professional opinion. The use of these standards and guidelines is subject to the clinician’s judgement in each individual case.

The College makes all reasonable efforts to ensure the quality and accuracy of the protocols and to update the protocols regularly. However subject to any warranties, terms or conditions which may be implied by law and which cannot be excluded, the protocols are provided on an "as is" basis. The College does not warrant or represent that the protocols are complete, accurate, error-free, or up to date. The protocols do not constitute medical or professional advice. Users should obtain appropriate medical or professional advice, or where appropriately qualified, exercise their own professional judgement relevant to their own particular circumstances. Users are responsible for evaluating the suitability, accuracy, currency, completeness and fitness for purpose of the protocols.

Except as set out in this paragraph, the College excludes: (i) all warranties, terms and conditions relating in any way to; and (ii) all liability (including for negligence) in respect of any loss or damage (including direct, special, indirect or consequential loss or damage, loss of revenue, loss of expectation, unavailability of systems, loss of data, personal injury or property damage) arising in any way from or in connection with; the protocols or any use thereof. Where any statute implies any term, condition or warranty in connection with the provision or use of the protocols, and that statute prohibits the exclusion of that term, condition or warranty, then such term, condition or warranty is not excluded. To the extent permitted by law, the College's liability under or for breach of any such term, condition or warranty is limited to the resupply or replacement of services or goods.

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Contents

Scope ........................................................................................................ v

Abbreviations ............................................................................................ 6

Definitions ................................................................................................. 7

Introduction ............................................................................................ 10

Authority and development ..................................................................... 13

1 Pre-analytical ................................................................................ 16

2 Specimen handling and macroscopic findings ............................... 18

3 Microscopic findings ...................................................................... 23

4 Ancillary studies findings .............................................................. 32

5 Synthesis and overview ................................................................ 35

6 Structured checklist ...................................................................... 36

7 Formatting of pathology reports ................................................... 51

Appendix 1 Pathology request information and surgical handling procedures ................................................. 52

Appendix 2 Guidelines for formatting of a pathology report ....... 59

Appendix 3 Example of a pathology report ................................. 60

Appendix 4 WHO Classificationa of oesophageal tumours ........... 62

References .............................................................................................. 64

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Scope

This protocol contains standards and guidelines for the preparation of structured reports relating to endoscopic resection (ER) of pre-malignant and malignant lesions of the oesophagus and gastro-oesophageal junction. Endoscopic resection is the term used to describe the endoscopic removal of mucosal and superficial submucosal confined neoplastic lesions either by Endoscopic Submucosal Dissection (ESD) techniques (en-bloc resection) or by the previously termed Endoscopic Mucosal Resection (EMR) techniques (piecemeal for lesions > 2cm). Given that the submucosa is commonly included in EMR resection specimens Endoscopic Resection (ER) is the preferred term to encompass specimens resected by both methods.

Endoscopic biopsy specimens are excluded. Surgically resected specimens are covered in a separate document.

Structured reporting aims to improve the completeness and usability of pathology reports for clinicians, and in particular to guide clinical decision making. The protocol provides a framework for reporting of any oesophageal and gastro-oesophageal junction ER specimens, whether as a minimum data set or fully comprehensive report. This approach also allows easy extraction of relevant information for cancer registries and for clinical, translational and basic research. The structured report allows flexibility in the report, including the provision of any appropriate additional information as free text.

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Abbreviations

AJCC American Joint Committee on Cancer ER Endoscopic Resection ESD Endoscopic Submucosal Dissection GOJ Gastro-oesophageal junction PBS Pharmaceutical Benefits Scheme RCPA Royal College of Pathologists of Australasia TNM tumour-node-metastasis UICC International Union Against Cancer WHO World Health Organization

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Definitions

The table below provides definitions for general or technical terms used in this protocol. Readers should take particular note of the definitions for ‘standard’, ‘guideline’ and ‘commentary’, because these form the basis of the protocol.

Ancillary study

An ancillary study is any pathology investigation that may form part of a cancer pathology report but is not part of routine histological assessment.

Clinical information

Patient information required to inform pathological assessment, usually provided with the specimen request form, also referred to as “pre-test information”.

Commentary Commentary is text, diagrams or photographs that clarify the standards (see below) and guidelines (see below), provide examples and help with interpretation, where necessary (not every standard or guideline has commentary).

Commentary is used to:

• define the way an item should be reported, to foster reproducibility

• explain why an item is included (e.g. how does the item assist with clinical management or prognosis of the specific cancer).

• cite published evidence in support of the standard or guideline

• state any exceptions to a standard or guideline.

In this document, commentary is prefixed with ‘CS’ (for commentary on a standard) or ‘CG’ (for commentary on a guideline), numbered to be consistent with the relevant standard or guideline, and with sequential alphabetic lettering within each set of commentaries (eg CS1.01a, CG2.05b).

General commentary

General commentary is text that is not associated with a specific standard or guideline. It is used:

• to provide a brief introduction to a chapter, if necessary

• for items that are not standards or guidelines but are included in the protocol as items of potential importance, for which there is currently insufficient evidence to recommend their inclusion. (Note: in future reviews of protocols, such items may be reclassified as either standards or guidelines, in line with diagnostic and prognostic advances, following evidentiary review).

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Guideline Guidelines are recommendations; they are not mandatory, as indicated by the use of the word ‘should’. Guidelines cover items that are not essential for clinical management, staging or prognosis of a cancer, but are recommended.

Guidelines include key observational and interpretative findings that are fundamental to the diagnosis and conclusion. Such findings are essential from a clinical governance perspective, because they provide a clear, evidentiary decision-making trail.

Guidelines are not used for research items.

In this document, guidelines are prefixed with ‘G’ and numbered consecutively within each chapter (eg G1.10).

Macroscopic findings

Measurements or assessment of a biopsy specimen made by the unaided eye.

Microscopic findings

In this document, the term ‘microscopic findings’ refers to histo-morphological assessment.

Predictive factor

A predictive factor is a measurement that is associated with response or lack of response to a particular therapy.

Prognostic factor

A prognostic factor is a measurement that is associated with clinical outcome in the absence of therapy or with the application of a standard therapy. It can be thought of as a measure of the natural history of the disease.

Standard Standards are mandatory, as indicated by the use of the term ‘must’. Their use is reserved for core items essential for the clinical management, staging or prognosis of the cancer and key information (including observations and interpretation) which is fundamental to the diagnosis and conclusion. These elements must be recorded and at the discretion of the pathologist included in the pathology report according to the needs of the recipient of the report.

The summation of all standards represents the minimum dataset for the cancer.

In this document, standards are prefixed with ‘S’ and numbered consecutively within each chapter (eg S1.02).

Structured report

A report format which utilises standard headings, definitions and nomenclature with required information.

Synoptic report

A structured report in condensed form (as a synopsis or precis).

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Synthesis Synthesis is the process in which two or more pre-existing elements are combined, resulting in the formation of something new.

The Oxford dictionary defines synthesis as “the combination of components or elements to form a connected whole”.

In the context of structured pathology reporting, synthesis represents the integration and interpretation of information from two or more modalities to derive new information.

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Introduction

Oesophageal and Gastro-oesophageal Junction Cancer

The College of American Pathologists (CAP), Association of Directors of Anatomic and Surgical Pathology (ADASP) and the Royal College of Pathologists (United Kingdom) have recently published protocols for the reporting of oesophageal cancer. 1-3 There are no specifically dedicated protocols relating to the handling and reporting of specimens from the oesophagus removed using ER techniques.

Endoscopic resections are performed as diagnostic staging and therapeutic procedures. Results may determine further management and treatment of a variety of precursor lesions and early cancers (T1N0). This has now become the standard of care in Japan.4-6

In some western centres the experience of handling specimens of endoscopic resections may be limited, however given the significant advantages of ER in contrast with oesophagectomy with respect to the associated morbidity and mortality, these techniques are rapidly being adopted and therefore pathologists are more likely to encounter these specimens.

Endoscopic resections are usually performed subsequent to a diagnosis of high-grade intraepithelial neoplasia (dysplasia), early malignancy (T1N0) or nodular lesions with any grade of intraepithelial neoplasia.7 Although there is no universal consensus, the term "intraepithelial neoplasia" (IEN) is preferred over the term dysplasia to encompass all non-invasive neoplasia, whether based on traditional morphological features or on clonal/molecular abnormalities in the absence of the traditional morphological abnormalities.8

The application of a standardised protocol by pathologist for handling, grossing, and assessing ER specimens is critical for consistent accurate diagnosis thereby enabling appropriate clinical decision-making. All specimens provided by ER techniques should be handled and reported as surgical specimens paying particular attention to maintenance of proper orientation, meticulous macroscopic examination, accurate lesion mapping and appropriate morphologic diagnosis. This publication aims to fulfil this need by incorporating available relevant evidence-based information and collective opinions from an expert multidisciplinary group. The intention is to provide pathologists with a minimum dataset and guidelines that are comprehensive and easy to use. It is hoped that this will help the clinicians to manage the patients optimally.

Given this background, structured reporting of endoscopic resections of pre-malignant lesions and early cancers of the oesophagus and gastro-oesophageal junction aims at "guiding/teaching" to ensure that reporting is up to a desired standard, "enhancing" the practice of pathology with regards to these lesions, "inducing" the clinicians to undertake appropriate management and "promoting" relevant advanced research in Australia.

Importance of histopathological reporting

The role of the histopathologist in reporting endoscopic resections is to confirm the endoscopic abnormality and to provide information that would enable clinicians to decide on further management and staging of the lesion. Thus, the outcomes of endoscopic resections should include a report that would confirm or modify the pre-

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procedure diagnosis with information about (1) the presence or absence of intraepithelial neoplasia/dysplasia and the severity (2) the presence or absence of malignancy, and if malignancy is present, (3) the degree of differentiation, (4) the status of the margins (lateral and deep), ie. completeness of excision, (5) the depth of invasion and (6) the status of vascular invasion, especially in cases with submucosal invasion (stage T1b). There is evidence that the degree of differentiation, the depth of invasion and lympho-vascular invasion seen in endoscopic resection specimens, may be predictors of lymph node metastasis and therefore indicate the need for surgical management as definitive therapy.9-10

Technical issues and artefacts such as haemorrhage, electro-diathermy effect, and poor preparation of specimens with shrinkage that would hamper accurate histologic interpretation should be conveyed to the clinicians for the purpose of quality improvement.

Benefits of structured reporting

It is not uncommon to find inconsistencies in pathology reports within single institutions, across organisations, states and countries. The single most effective way to overcome this situation is to create a standardised reporting system that will ensure that key pathological features necessary for patient management and prognostication are included. It is also desirable to document important features in a systematic fashion for the purposes of audits, tumour registries and research.

Design of this protocol

This protocol defines the relevant information to be assessed and recorded in a pathology report for lesions of the oesophagus and gastro-oesophageal junction removed by ER. Mandatory elements (standards) are differentiated from those that are not mandatory but represent best practice (guidelines). Also, items suited to tick boxes are distinguished from more complex elements requiring free text or narrative. The structure provided in the following chapters, headings and subheadings describe the elements of information and their groupings, but does not necessarily represent the format of either a pathology report or a checklist. These and the structured pathology request form (Appendix 1) are templates that represent information from this protocol, organised and formatted differently to suit different purposes.

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Key documentation

• Guidelines for Authors of Structured Cancer Pathology Reporting Protocols11

• The Pathology Request-Test-Report Cycle — Guidelines for Requesters and Pathology Provider12

• WHO Classification of tumours, Pathology and Genetics of Tumours of the Digestive System, 2010, 4th edition8

• AJCC Cancer Staging Manual, 7th edition, 201013

• The Paris endoscopic classification of superficial neoplastic lesions: esophagus, stomach, and colon14

Updates since last edition

Not applicable

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Authority and development

This section provides details of the committee involved in developing this protocol and the process by which it was developed.

Protocol developers

This protocol was developed by an expert committee, with assistance from relevant stakeholders.

Expert committee

Clinical Prof Priyanthi Kumarasinghe (Chair and lead author), Pathologist

Dr Ian Brown, Pathologist

Dr Amanda Charlton, Pathologist

Clin A/Prof Bastiaan de Boer, Pathologist

A/Prof Robert Eckstein, Pathologist

Dr Krishna Epari, Surgeon

Dr Anthony Gill, Pathologist

Prof Alfred Lam, Pathologist

Prof Gregory Lauwers, Pathologist

Dr Cathy Streutker, Pathologist

Dr Spiro Raftopoulos, Gastroenterologist

Prof Michael Bourke, Gastroenterologist

A/Prof Timothy Price, Medical Oncologist

International Liaison

Dr Mary K Washington, Chair of the Gastrointestinal Tumors Cancer Committee, College of American Pathologists.

Acknowledgements

The oesophageal tumour expert committee wish to thank all the pathologists and clinicians who contributed to the discussion around this document.

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Stakeholders

ACT Health

Anatomical Pathology Advisory Committee (APAC)

Australian Association of Pathology Practices Inc (AAPP)

Australian Cancer Network

Australian Commission on Safety and Quality in Health Care

Cancer Australia

Cancer Control New Zealand

Cancer Council ACT

Cancer Council NSW

Cancer Council Queensland

Cancer Council SA

Cancer Council Tasmania

Cancer Council Victoria

Cancer Council Western Australia

Cancer Institute NSW

Cancer Services Advisory Committee (CanSAC)

Cancer specific expert groups – engaged in the development of the protocols

Cancer Voices

Clinical Oncology Society of Australia (COSA)

Colorectal Cancer Research Consortium

Department of Health and Ageing

Gastroenterological Society of Australia GESA

Grampians Integrated Cancer Services (GICS)

Health Informatics Society of Australia (HISA)

Independent Review Group of Pathologists

Medical Software Industry Association (MSIA)

National Breast and Ovarian Cancer Centre (NBOCC)

National Coalition of Public Pathology (NCOPP)

National E-Health Transition Authority (NEHTA)

National Pathology Accreditation Advisory Council (NPAAC)

National Round Table Working Party for Structured Pathology Reporting of Cancer.

New Zealand Guidelines Group (NZGG)

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New Zealand Ministry of Health

New Zealand Society of Gastroenterology (NZSG)

NSW Department of Health

Peter MacCallum Cancer Institute

Queensland Cooperative Oncology Group (QCOG)

Representatives from laboratories specialising in anatomical pathology across Australia

Royal Australasian College of Physicians (RACP)

Southern Cancer Network, Christchurch, New Zealand

Southern Melbourne Integrated Cancer Service (SMICS)

Standards Australia

The Medical Oncology Group of Australia

The Royal Australasian College of Surgeons (RACS)

The Royal Australian and New Zealand College of Radiologists (RANZCR)

The Royal Australian College of General Practitioners (RACGP)

The Royal College of Pathologists of Australasia (RCPA)

Victorian Cooperative Oncology Group (VCOG)

Western Australia Clinical Oncology Group (WACOG)

Secretariat

Meagan Judge, Royal College of Pathologists of Australasia.

Development process

This protocol has been developed following the nine-step process set out in Guidelines for Authors of Structured Cancer Pathology Reporting Protocols.11

Where no reference is provided, the authority is the consensus of the expert group.

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1 Pre-analytical

This chapter relates to information that should be recorded on receipt of the specimen in the laboratory.

The pathologist is reliant on the quality of information received from the clinicians or requestor. Some of this information may be received in generic pathology request forms, however, the additional information required by the pathologist specifically for the reporting of endoscopic resections is outlined in Appendix 1 which also includes a standardised request information sheet that may be useful in obtaining all relevant information from the requestor.

Surgical handling procedures affect the quality of the specimen and recommendations for appropriate surgical handling are included in Appendix 1.

S1.01 All demographic information provided on the request form and with the specimen must be recorded.

CS1.01a The Royal College of Pathologists of Australasia (RCPA) The Pathology Request-Test-Report Cycle — Guidelines for Requesters and Pathology Providers must be adhered to.15 This document specifies the minimum information to be provided by the requesting clinician for any pathology test.

CS1.01b The patient’s ethnicity must be recorded, if known. In particular whether the patient is of Aboriginal or Torres Strait islander origin. This is in support of a government initiative to monitor the health of indigenous Australians particularly in relation to cancer.

CS1.01c The patient’s health identifiers may include the patient’s Medical Record Number as well as a national health number such as a patient’s Medicare number (Australia), Individual Healthcare Identifier (IHI) (Australia) or the National Healthcare Identifier (New Zealand).

S1.02 All clinical information as documented on the request form must be recorded verbatim.

CS1.02a The request information may be recorded as a single text (narrative) field or it may be recorded atomically.

S1.03 The pathology accession number of the specimen must be recorded.

S1.04 The principal clinician involved in the patient’s care and responsible for investigating the patient must be recorded.

CS1.04a The requesting clinician (identified under S1.01) may be the doctor who performs the surgery or biopsy, and may not be the person with overall responsibility for investigating and managing the patient. Identification of the principal clinician is essential, to ensure that pathological and clinical information is communicated

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effectively.

CS1.04b Knowledge of the clinical presentation is an essential part of the WHO classification yet it may not be available for a number of reasons:

• The clinical assessment and staging may be incomplete at the time of endoscopic resection

• The pathology request is often authored by the clinician performing the endoscopic resection rather than the clinician who is investigating and managing the patient

• The identity of this clinician is often not indicated on the pathology request form

In practice therefore, it is important in such cases that the reporting pathologist should be able to communicate with the managing clinician for clarification.

S1.05 The proceduralist’s identity and contact details must be recorded.

G1.01 Any clinical information received in other communications from the requestor or other clinician should be recorded together with the source of that information.

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2 Specimen handling and macroscopic findings

This chapter relates to the procedures required after the information has been handed over from the requesting clinician and the specimen has been received in the laboratory.

Specimen handling

Generally the entire ER specimen is subjected to microscopic examination and it is unwise to procure tissue samples for tissue banking or research purposes except under exceptional circumstances. As a safeguard, research use of any part of the specimen should be put on hold until the diagnostic process is complete.

The number of endoscopic resections (ERs) separately received and/or in each container should be matched with the labelling and information provided on the request form and submitted separately as appropriate. The specimen(s) must be handled in a systematic and thorough fashion to ensure completeness and accuracy of pathological data.

• Specimen reception: Specimens are best received with the mucosa upward pinned on a cork board or similar firm base in the endoscopic suite. If not this should be done in the laboratory immediately on receipt of specimen. (Refer to Figure SH1 below).

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Figure SH1

•

Specimen measurement, fixation and orientation: Immediate pinning and fixing of the specimen help to preserve the tissue size, shape, and orientation. They are best fixed for at least 12 hours in formalin. After fixation, the surgical margins (lateral and deep) must be appropriately inked. Where orientation is required, the endoscopist should use the designation of O (oral) and A (anal) or P (proximal) and D (distal) marked on the board. In this situation it is necessary for the pathologists to specifically indicate the respective ends of the specimens. This will allow the endoscopist to be informed of the area that may require further resection. Care must be taken to orient the sections such that the circumferential (lateral) surgical margins are assessed, either “en bloc” or in cross sections, depending on the size of the specimen. A photograph will be helpful for mapping the lesion/margins and to document the macroscopic appearance of the lesion for comparison with the endoscopic impression (refer to Appendix 1 and Figure A1).

• A photograph, with a ruler in place, may be taken after removal of the pins.

• Specimen dissection: The specimen must be entirely submitted in sequential sections after ensuring the best possible orientation and routinely processed, cut and stained with hematoxylin and

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eosin. The specimen is cut into 2-3 mm (not less than 2 mm) parallel slices from one end to the other. If the specimen is oriented it can be cut along the oral/anal plane. The plane can be modified according to the margin of interest. The slices are serially placed into the cassettes starting with the first slice. No more than 4 slices are placed into 1 cassette. Circumferential (lateral) surgical margins are assessed, either “en bloc” or in cross section, depending on the size of the specimen. The first slice may be inverted to allow the margin to be sectioned first during histological evaluation (Refer to figure SH2). Larger/ longer cassettes may be used if the facility is available.

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Figure SH2 Mucosal slices


S2.01 All linear measurements are in SI units, unless explicitly stated.

S2.02 The specimen dimensions and maximum size of any visible lesion(s) must be recorded.

CS2.02a The specimen and any visible lesion(s) are measured in 2 dimensions. Note that the resected specimens tend to shrink considerably both before and after fixation, making measurements shorter than in vivo.

If there are multiple specimens, dimensions should be given for each.

G2.01 The gross appearance of the lesion(s) should be recorded.

S2.03 The distance from the lesion (if identifiable) to the nearest margin (cut edge) must be recorded.

S2.04 The nature and site of all blocks must be recorded.

CS2.04a A diagram or photograph showing the serial slices and a key to the blocks taken may be helpful. (See figure SH2

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above).

G2.02 A descriptive or narrative field should be provided to record any macroscopic information that is not recorded in the above standards and guidelines, and that would normally form part of the macroscopic description.

CG2.02a The traditional macroscopic narrative recorded at the time of specimen dissection is often reported separately from the cancer dataset. Although this remains an option, it is recommended that macroscopic information be recorded within the overall structure of this protocol.

CG2.03b Much of the information recorded in a traditional macroscopic narrative is covered in the standards and guidelines above and in many cases, no further description is required.

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3 Microscopic findings

This section relates to purely histological (morphological) assessment. Information derived from multiple investigational modalities, or from two or more chapters, is described in Chapter 5.

S3.01 The type of mucosa and tissue layers present must be recorded.

CS3.01a Options include:

• Mucosa (M)

o Glandular

o Squamous

o Mixed

• Muscularis mucosae (MM)

• Submucosa (SM)

Refer to Figure S3.01 below.

CS3.01b A comment should be made if muscularis mucosae is duplicated. Although attempts have been made to grade the extent this may not be practical in all cases.16

Submucosa is identified by the presence of large calibre thick walled vessels.

CS3.01c Muscularis propria may be present in some specimens. If muscularis propria is seen it may suggest that perforation has occurred.

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Figure S3.01 Tissue layers

S3.02 The type of lesion(s) present must be recorded.

CS3.02a

These types are:

1. No carcinoma or Intraepithelial neoplasia (IEN)

2. Indefinite for IEN/ Dysplasia

3. IEN/Dysplasia

4. Carcinoma

CS3.02b A comment should be made if neoplastic elements are present in a sub-squamous location.

CS3.02c IF IEN, complete S3.03 – S3.04.

CS3.02d If carcinoma, complete S3.05 – S3.09, G3.01, G3.02

S3.03 The histologic type of the intraepithelial neoplasia (IEN)/dysplasia must be recorded if present.

CS3.03a The histologic types will be either:

• Squamous

• Glandular

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S3.04 The histologic grade of the intraepithelial neoplasia (IEN)/dysplasia must be recorded if present.

CS3.04a For intraepithelial neoplasia(IEN)/dysplasia the histologic grade will be:

• Low

• High

• Indefinite

WHO guidelines should be used.

CS3.04b Atypia that raises concern but not diagnostic of dysplasia (IEN) is labelled “Indefinite for dysplasia” (IDD) in the tubular gut.8,17 This can be due to technical and/or interpretative difficulties. The form of dysplasia that is being recognised as crypt dysplasia where the dysplastic changes are confined to the crypts without surface involvement is likely to be called IDD by some.18-20 Although it is generally believed the worrisome atypia raises the possibility of a low grade lesion in practice, there may be features that may raise the possibility of a high grade lesion. This situation may arise in particular with increasing recognition of different morphological types of dysplasia associated with Barrett disease. Therefore it is prudent that the degree of uncertainty is correctly conveyed to the clinician. There is insufficient data regarding the biological potential of the diagnosis of IDD.20 Currently there are no strict guidelines regarding the management of these lesions.

S3.05 If carcinoma, the histologic type must be recorded.

CS3.05a Record the histologic type according to the WHO classification8:

• Squamous cell carcinoma

• Adenocarcinoma

• Adenoid cystic carcinoma

• Adenosquamous carcinoma

• Basaloid squamous cell carcinoma

• Mucoepidermoid carcinoma

• Spindle cell (squamous) carcinoma

• Verrucous (squamous) carcinoma

• Undifferentiated carcinoma

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S3.06 If carcinoma, the histologic grade must be recorded.

CS3.06a The tumour should receive a histological gradea

• GX Grade cannot be assessed – stage grouping as G1

based on the AJCC classification13:

• G1 Well differentiated

• G2 Moderately differentiated

• G3 Poorly differentiated

• G4 Undifferentiated – stage grouping as G3 squamous.

CS3.06b It is important to document the presence of poorly and undifferentiated components as this might influence the decision for surgery.21

G3.01 If adenocarcinoma, the phenotype of the tumour may be recorded.22-

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CG3.01a This may be recorded as one of the following:

• Intestinal

• Gastric

• Mixed/hybrid

CG3.01b Immunohistochemical stains may be useful to suggest a phenotype (refer to chapter 4).

S3.07 If carcinoma, the tumour size must be specified.

CS3.07a Size must be recorded in maximal dimension for each tumour identified.

S3.08 If carcinoma, the depth of invasion must be recorded.

CS3.08a The depth of invasion should be recorded according to the AJCC13:

• Cannot be assessed

• T1a – tumour invades lamina propria or muscularis mucosae

• T1b - Tumour invades submucosa

S3.09 If adenocarcinoma or squamous cell carcinoma, an additional level of detail on depth of invasion must be recorded.

a Used with the permission of the American Joint Committee on Cancer (AJCC), Chicago, Illinois. The original source for this material is the AJCC Cancer Staging Manual, Seventh Edition (2010) published by Springer Science and Business Media LLC, www.springerlink.com.

http://www.springerlink.com/�

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CS3.09a There is evidence that depth of tumour invasion provides additional information about the need for surgical management and/or other forms of therapy as definitive treatment.9,10,21,24 There are 2 methods to further subdivide the depth of invasion. The method, AJCC or Stolte should be recorded in the report.

CS3.09b The first is based on recommendations by AJCC on the subdivisions of the mucosa and as described by Hölscher et al.9 This system subdivides both mucosal invasion (T1a) and submucosal invasion (T1b) into 3 levels (see Figure CS3.09b below). This system is applicable to both squamous and adenocarcinomas.

In the AJCC, T1a is sub-divided as M1-M3

• m1 - In situ

• m2 - into the lamina propria

• m3 – into the muscularis mucosae

T1b is sub-divided as SM1-3

This division may be difficult and essentially depends on the amount of submucosa included in the specimen. Division of submucosal invasion will not be applicable to lesions that are T1a. When there is submucosal invasion in an ER specimen subdivision may not be accurate as the full thickness of the submucosa is often not included.

• sm1 – superficial 1/3 submucosa

• sm2 – intermediate one third of submucosa

• sm3 – outer one third of submucosa

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Figure: CS3.09b Early carcinoma: Depth of tumour infiltration (3 mucosal tiers)

CS3.09c The second is a 4 tiered system recommended by Stolte25 and others to assess mucosal invasion of adenocarcinomas (see figure CS3.09c (i) below). Their recommendations take into account the duplication of muscularis mucosae that occurs in columnar lined mucosa and Barrett oesophagus (see figure CS3.09c (ii) below). The duplicated muscularis mucosae shows an inner layer of muscularis mucosae, which is identified immediately deep to the lamina propria, and an outer layer of muscularis mucosae, that lies immediately superficial to the submucosa. The space between the duplicated muscularis mucosae is loose connective tissue and thin-walled vessels (capillaries). Large-calibre, thick-walled blood vessels such as large arteries are not seen in this space in between the inner and outer layers of muscularis mucosa.26,27,16,24,28 They draw a distinction between the different levels of invasion within the duplicated muscularis mucosa as there is emerging evidence that this may correlate with a difference in the behaviour of T1a adenocarcinomas.29 More importantly it is important to appreciate the presence of duplicated and distorted muscularis mucosa in these lesions to avoid misinterpretation of muscle invasion.

In Stolte, T1a is sub-divided as M1-M3


29

• m2 - into the superficial/inner muscularis mucosae

• m3 - into the space between the layers of the muscularis mucosae

• m4 - into the outer/true muscularis mucosae

T1b subdivision is similar to AJCC based system.

Figure: CS3.09c (i) Early carcinoma: Depth of tumour infiltration (4 mucosal tiers)

30

Figure: CS3.09c (ii) Duplication of muscularis mucosae

S3.10 If carcinoma, the presence or absence of vascular space invasion in small (lymphatic and capillary) and large (vein and artery) calibre vessels must be recorded.

G3.02 If carcinoma, the presence or absence of perineural invasion should be recorded.

G3.03 The presence or absence of tumour budding should be recorded.

CG3.03a Tumour budding can be defined as the presence of single cells or small groups of less than 5 undifferentiated cells at the invasive front of the carcinoma. More than 5 tumour buds per square mm has been proposed as a high rate of tumour budding.

There is early evidence suggesting that tumour budding may represent an adverse prognostic indicator. However, at the current time there is insufficient evidence to support its routine reporting and it should be considered optional as well as investigational.30-31

S3.11 The margin status must be recorded.

CS3.11a Record whether the deep and lateral margins are involved or not involved by:

1. Carcinoma

31

2. IEN/Dysplasia

If not involved, record the distance of tumour to the closest margin (in mm) in either case where appropriate.

CS3.11b If multiple specimens are submitted, the deep and lateral margin status should be assessed as above if the specimens are oriented and the margin status has been requested by the surgeon. Lateral margin status may not be required in some specimens and this decision needs clear communication between the pathologists and the endoscopist.

S3.12 The presence or absence of other pathologies must be specified.

CS3.12a Other pathologies may include:

• IEN in cases of carcinoma

• Ulceration

• Scar formation

• Columnar metaplasia

• Goblet cells

• Infection

• Foreign body

• Other changes related to previous treatment

• Other neoplasms eg granular cell tumours

• Other (specify)

G3.04 Any additional relevant microscopic comments should be recorded.

32

4 Ancillary studies findings

G4.01 The results of any ancillary tests performed should be recorded.

CG4.01a Ancillary tests have been used to support the diagnosis of intraepithelial neoplasia (IEN)/dysplasia or carcinoma at the discretion of the pathologist. At this point in time there is limited evidence for their utility.

CG4.01b Immunohistochemical stains may be performed to identify phenotypes. MUC2, CD10, villin and CDX2 are known to be positive in intestinal phenotype and MUC5AC and MUC6 in gastric phenotypes.22-23,32-33 The significance of this has not been determined.

CG4.01c Ancillary tests may be used to add additional information or confirmation e.g. D2 40, CD 34, CD31 to assess lympho-vascular invasion.

CG4.01d Her 2 over expression is reported in approximately 15 -25% of gastric/gastro-oesophageal junction (GOJ) adenocarcinomas in Western countries including Australia (range 2-45% for GOJ and 9-60% for oesophagus).34,35

Trastuzumab-based therapy offers a significant survival advantage for patients with HER2 overexpressing locally advanced, recurrent or metastatic gastric/gastro-oesophageal adenocarcinomas compared to conventional therapy alone. The efficacy for low stage, non-metastatic GOJ or EAC is currently unknown.

CG4.01e At present, no specific ancillary tests are routinely recommended for oesophageal tumour classification. In the case of occasional poorly differentiated carcinoma, mucin stains (positive, albeit often focal, in adenocarcinoma), high molecular weight cytokeratin (eg CK5/6; positive in SCC) and p63 and/or p40 (ΔNp63) (positive in SCC) may help distinguish SCC from adenocarcinoma and basaloid squamous carcinoma from adenoid cystic carcinoma.

Spindle cell (squamous) carcinoma will express cytokeratin, aiding distinction from primary sarcomas and melanoma.

33

Table G4.01: Morphologic and immunohistochemical features of dysplasia

Pattern of dysplasia

Morphologic features

MUC2 MUC5ac MUC6 CDX-2 Villin CD10

Intestinal (adenomatous) See figure G4.01(i)

- Columnar cells - Hyperchromatic,

pencillate, stratified nuclei

- Dense eosinophilic cytoplasm

+ ± - + + +

Gastric foveolar (non adenomatous) See figure G4.01(ii)

- Cuboidal to columnar cells with pale clear to light eosinophilic cytoplasm

- Hyperchromatic round to oval nuclei

- Prominent nucleoli if high grade

- + rare - - -

Hybrid - Cytological features intermediate between the above patterns

- Or an intimate admixture of both

± + ± ± ± ±

Serrated - Resembling colorectal serrated lesions

- Poorly characterised at present

?(+) ?(+) ? ?(+) ? ?

Pyloric gland - Closely packed tubules lined by cuboidal to columnar epithelium with pale to eosinophilic ground glass cytoplasm

- Round basal nuclei - Nucleoli easily

visible

- + (surface)

+ - - -

34

Figure G4.01(i) Intestinal panel

Figure G4.01(ii) Gastric foveolar panel

H&E

VILLIN MUC2

CDX-2

H&E

VILLIN MUC5ac

CDX-2

35

5 Synthesis and overview

Information that is synthesised from multiple modalities and therefore cannot reside solely in any one of the preceding chapters is described here.

By definition, synthetic elements are inferential rather than observational, often representing high-level information that is likely to form part of the report ‘Summary’ or ‘Diagnosis’ section in the final formatted report.

Overarching case comment is synthesis in narrative format. Although it may not necessarily be required in any given report, the provision of the facility for overarching commentary in a cancer report is essential.

G5.01 The ‘Diagnostic summary’ section of the final formatted report should include:

• Type of lesion (S3.02)

o If carcinoma record:

Histologic type

Histologic grade

Depth of invasion

Margin Status

Vascular invasion

Presence of other pathologies

o If IEN record:

Histologic grade

Margin status


G5.02 A field for free text or narrative in which the reporting pathologist can give overarching case comment must be provided.

CG5.02a This field may be used, for example, to:

• list any relevant ancillary tests

• document any noteworthy adverse gross and/or histological features

• express any diagnostic subtlety or nuance that is beyond synoptic capture

• document further consultation or results still pending.

CG5.02b Use of this field is at the discretion of the reporting pathologist.

36

6 Structured checklist

The following checklist includes the standards and guidelines for this protocol which must be considered when reporting, in the simplest possible form. The summation of all “Standards” is equivalent to the “Minimum Data Set” for oesophageal tumours. For emphasis, standards (mandatory elements) are formatted in bold font.

S6.01 The structured checklist provided below may be modified as required but with the following restrictions:

a. All standards and their respective naming conventions, definitions and value lists must be adhered to.

b. Guidelines are not mandatory but are recommendations and where used, must follow the naming conventions, definitions and value lists given in the protocol.

G6.01 The order of information and design of the checklist may be varied according to the laboratory information system (LIS) capabilities and as described in Functional Requirements for Structured Pathology Reporting of Cancer Protocols.36

CG6.01a Where the LIS allows dissociation between data entry and report format, the structured checklist is usually best formatted to follow pathologist workflow. In this situation, the elements of synthesis or conclusions are necessarily at the end. The report format is then optimised independently by the LIS.

CG6.01b Where the LIS does not allow dissociation between data entry and report format, (for example where only a single text field is provided for the report), pathologists may elect to create a checklist in the format of the final report. In this situation, communication with the clinician takes precedence and the checklist design is according to principles given in Chapter 7.

G6.02 Where the checklist is used as a report template (see G6.01), the principles in Chapter 7 and Appendix 2 apply.

CG6.02a All extraneous information, tick boxes and unused values should be deleted.

G6.03 Additional comment may be added to an individual response where necessary to describe any uncertainty or nuance in the selection of a prescribed response in the checklist. Additional comment is not required where the prescribed response is adequate.

37

Values in italics are conditional on previous responses.

Values in all caps are headings with sub values.

S/G Item description Response type Conditional

Clinical information and surgical handling

S1.01 Demographic information provided

S1.02 Clinical information provided on request form

Text

OR

Structured entry as below:

Tumour morphology Multi select value list (select all that apply):

• Polypoid

o 0-Ip (protruded, pedunculated)

o 0-Is (protruded, sessile; >2.5mm above baseline)

• Non-Polypoid

o 0-IIa (superficial, elevated; < 2.5mm above baseline)

o 0-IIb (flat)

o 0-IIc (superficial shallow, depressed)

o 0-III (excavated/ulcerated)

38


Lesion type Single selection value list:

• Focal lesion

• Non-focal lesion

If focal, record the site and location of the lesion as well as the distal extent and proximal extent.

Site(s) of the lesion Multi select value list (select all that apply):

• cervical oesophagus

• upper thoracic

• middle thoracic

• lower thoracic

• gastro-oesophageal junction

Location Text: (describe using a clock face orientation)

Distal extent Numeric: ___cm

This is the most distal extent of the lesion from the incisors

Note

Proximal extent Numeric: ___cm

This is the most proximal extent of the lesion

Note

39


from the incisors

Type of procedure Single selection value list:

• Endoscopic Resection (ER)

• Endoscopic Submucosal Dissection (ESD)

• Other

If other, please specify details

Details Text

Existence of local residual neoplasia

Text

Previous pathological diagnosis

Text

S1.03 Pathology accession number Alpha-numeric

S1.04 Principal clinician caring for the patient

Text

S1.05 Proceduralist’s name & contact details

Text

G1.01 Additional information Text


40


S2.02 Specimen dimensions Numeric: ___x___mm

1. length x width

Notes:

2. Specimen dimensions should be repeated for each

specimen received.

Maximum lesion size Numeric: ___x___mm

OR

No macroscopically visible lesions

1. length x width

Notes:

2. Lesion size should be repeated for each

If macroscopically visible lesions then consider reporting G2.01 and report S2.03.

visible lesion noted.

G2.01 Gross appearance of lesion(s) Text

S2.03 Distance of lesion from closest margin

Numeric: ___mm

OR

Not identifiable

S2.04 Nature and site of all blocks Text

41


G2.02 Other macroscopic comment Text

Microscopic findings

S3.01 Tissue layers present Multi select value list (select all that apply):

• Mucosa

o Squamous

o Glandular

o Glandular & squamous

• Muscularis mucosae

• Submucosa

• Muscularis propria

S3.02 Type of lesion Single selection value list:

1. No carcinoma and Intraepithelial neoplasia (IEN)

2. Indefinite for IEN/ Dysplasia

3. Intraepithelial neoplasia(IEN)/Dysplasia

4. Carcinoma

If carcinoma, complete S3.05-S3.10 and consider G3.01 and G3.02

If IEN complete S3.03 – S3.04.

If Carcinoma or IEN, record whether the neoplastic elements are in a sub-squamous location.

Neoplastic elements in sub- Text

42


squamous location?

S3.03 Histological type - IEN/dysplasia

Single selection value list:

• Squamous

• Glandular

Conditional on IEN/dysplasia being recorded in S3.02.

S3.04 Histological grade -IEN/dysplasia


• Low

• High

• Indefinite

Conditional on IEN/dysplasia being recorded in S3.02.

S3.05 Histologic type - carcinoma Single selection value list:

• Squamous cell carcinoma

• Adenocarcinoma

• Adenoid cystic carcinoma

• Adenosquamous carcinoma

• Basaloid squamous cell carcinoma

• Mucoepidermoid carcinoma

• Spindle cell (squamous) carcinoma

• Verrucous (squamous) carcinoma

• Undifferentiated carcinoma

Conditional on carcinoma being recorded in S3.02.

S3.06 Histologic grade-carcinoma Single selection value list: Conditional on carcinoma being

43


• Not applicable

• GX Grade cannot be assessed

• G1 Well differentiated

• G2 Moderately differentiated

• G3 Poorly differentiated

• G4 Undifferentiated

recorded in S3.02.

G3.01 Phenotype Single selection value list:

• Intestinal

• Gastric

• Mixed/hybrid

Conditional on adenocarcinoma being recorded in S3.02.

S3.07 Tumour size Numeric: ___mm

1. Maximum dimension

Notes:

2. Tumour size should be repeated for each


tumour noted.

S3.08 Depth of invasion Single selection value list:

• Cannot be assessed

• T1a – tumour invades lamina propria or muscularis mucosae

• T1b - Tumour invades submucosa


44


S3.09 Additional detail - depth of invasion

Note: 1 or both of the below subdivisions may be reported.

Conditional on adenocarcinoma or squamous cell carcinoma being recorded in S3.02.

3-tiered (AJCC) Single selection value list:

• m1 - In situ


• m3 – into the muscularis mucosae

• sm1 – superficial 1/3 submucosa

• sm2 – intermediate one third of submucosa

• sm3 – outer one third of submucosa

4-tiered (Stolte) Single selection value list:


• m2 - into the superficial/inner muscularis mucosae

• m3 - into the space between the layers of the muscularis mucosae

• m4 - into the outer/true muscularis mucosae

Conditional on adenocarcinoma or squamous cell carcinoma being recorded in S3.02.

45


S3.10 Lymphatic and capillary space invasion


• Absent

• Present


Vein and artery space invasion


• Absent

• Present

G3.02 Perineural invasion Single selection value list:

• Absent

• Present


G3.03 Tumour budding Single selection value list:

• Absent

• Present

S3.11 SURGICAL MARGIN STATUS Note

If multiple specimens are submitted, the deep and lateral margin status should be assessed for each specimen if the specimens are oriented and the margin status has been requested by the endoscopist.

46


Deep margin Single selection value list:

• Involved

• Not involved

If involved, specify what it is “involved by”.

If not involved, record the distance of tumour to closest margin

Involved by Single selection value list:

1. Carcinoma

2. IEN/Dysplasia

3. Both Carcinoma and IEN/Dysplasia

Distance to closest margin Numeric: ___mm

Lateral margin Single selection value list:

• Involved

• Not involved

If involved, specify what it is “involved by”.

If not involved, record the distance of tumour to closest margin

47


Involved by Single selection value list:

1. Carcinoma

2. IEN/Dysplasia

3. Both Carcinoma and IEN/Dysplasia

Distance to closest margin Numeric: ___mm OR Not applicable

S3.12 Other pathologies Single selection value list:

• IEN in cases of carcinoma

• Ulceration

• Scar formation

• Columnar metaplasia

• Goblet cells

• Infection

• Foreign body

• Other changes related to previous treatment

• Other neoplasms eg granular cell tumours

If ‘other’, record details

48


• Other (specify)

Details Text

G3.04 Other microscopic comment Text

Ancillary test findings

G4.01 ANCILLARY TESTS

Performed Single selection value list:

• No

• Yes

If yes, record test type

Test type eg IHC, MUC etc Text

Note: Test result type, result and interpretive comment will need to repeat for each

If IHC, record the antibodies

ancillary test performed.

Antibodies List (as applicable) all:

• Positive antibodies

• Negative antibodies

• Equivocal antibodies

49


Result Text

Note:

Test result type, result and interpretive comment will need to repeat for each other ancillary test performed.

Interpretive comment Text

Note:

Test result type, result and interpretive comment will need to repeat for each other ancillary test performed.

Synthesis and overview

G5.01 Diagnostic summary

Include: • Type of lesion (S3.02)

o If carcinoma record:

Histologic type

Histologic grade

Depth of invasion

Margin status

Vascular invasion

Presence of other

Text

50


pathologies

o If IEN record:

Histologic grade

Margin status


G5.02 Overarching comment Text

51

7 Formatting of pathology reports

Good formatting of the pathology report is essential for optimising communication with the clinician, and will be an important contributor to the success of cancer reporting protocols. The report should be formatted to provide information clearly and unambiguously to the treating doctors, and should be organised with their use of the report in mind. In this sense, the report differs from the structured checklist, which is organised with the pathologists’ workflow as a priority.

Uniformity in the format as well as in the data items of cancer reports between laboratories makes it easier for treating doctors to understand the reports; it is therefore seen as an important element of the systematic reporting of cancer. For guidance on formatting pathology reports, please refer to Appendix 2.

52

Appendix 1 Pathology request information and surgical handling procedures

This appendix describes the information that should be collected before the pathology test. Some of this information can be provided on generic pathology request forms; any additional information required specifically for the reporting of cancers of the Oesophagus and Gastro-oesophageal Junction may be provided by the clinician on a separate request information sheet. An example request information sheet is included below. Elements which are in bold text are those which pathologists consider to be required information. Those in non-bold text are recommended.

Also included in this appendix are the procedures that are recommended before handover of specimens to the laboratory.

Patient information

Adequate demographic and request information should be provided with the specimen.

• Items relevant to cancer reporting protocols include:

• patient name

• date of birth

• sex

• identification and contact details of requesting doctor

• date of request

• The patient’s ethnicity should be recorded, if known. In particular whether the patient is of aboriginal or Torres Strait islander origin. This is in support of a government initiative to monitor the health of indigenous Australians particularly in relation to cancer.

The patient’s health identifiers should be provided.

• The patient’s health identifiers may include the patient’s Medical Record Number as well as a national health number such as a patient’s Medicare number (Australia), Individual Healthcare Identifier (IHI) (Australia) or the National Healthcare Identifier (New Zealand).

Clinical Information

The endoscopic tumour morphology should be recorded in accordance with the Paris Classification of superficial neoplastic lesions.14

• This information is best attained at time of gastroscopy by the requesting clinician.

53

• Select all that apply:

• Polypoid

o 0-Ip (protruded, pedunculated)

o 0-Is (protruded, sessile; >2.5mm above baseline)

• Non-Polypoid

o 0-IIa (superficial, elevated; < 2.5mm above baseline)

o 0-IIb (flat)

o 0-IIc (superficial shallow, depressed)

o 0-III (excavated/ulcerated)

Refer to Figures A1(i) and (ii) below.

Refer to Figures A2(i), (ii) and (iii) below for examples of common endoscopic lesions.

54

Figure A1 (i) Neoplastic lesions with “superficial” morphology

Figure A1 (ii) Schematic representation of the major variants of type 0 neoplastic lesions of the digestive tract.

The major variants of type 0 neoplastic lesions of the digestive tract: polypoid (lp and ls), non-polypoid (IIa, IIb and IIc), non-polypoid and excavated (III). Terminology as proposed in a consensus macroscopic description of superficial neoplastic lesions.14

55

Figure A2 (i) 0-IIb

1A 0-IIb(flat)15mm lesion in the 9 o’clock position within a C1M3 Barrett segment. 1B The lesion was removed en-bloc. 1C A hemi-circumferential resection of the Barrett segment has been performed

using the Duette system. Histology showed high-grade intraepithelial neoplasia/dysplasia.

Figure A2 (ii) 0-IIb+c

2A 20mm 0-IIb+c (flat with depressed areas) lesion in the 3 o’clock position 2B The edges of the lesion are marked 2C The lesion has been completely excised with the uninvolved Barrett beneath

removed to the level of the Gastro-Oesophageal Junction. All markers placed have been removed confirming complete macroscopic resection. Histology showed intramucosal cancer with free lateral and deep margins.

Figure A2 (iii) 0-IIa+c 3A Overview of a 0-IIa+c lesion in the 2 o’clock position within a C1 M3 segment 3B Close up of a 0-IIa+c lesion 3C Complete excision by EMR using the Duette system. Histology showed

intramucosal cancer with free lateral and deep margins

1 A 1 B 1 C

2 A 2 B 2 C

3 A 3 B 3 C

3 A 3 B 3 C

56

For focal lesions the location/site should be recorded.

• Choose from the following list (select all that apply):

• cervical oesophagus

• upper thoracic

• middle thoracic

• lower thoracic

• gastro-oesophageal junction

• Location should also be described in a neutral position using a clock face orientation.

• Lesion distance above the gastric fold (distal extent) and distance below the incisors (proximal extent) should be recorded by the proceduralist.

• Accurate recording of the site will facilitate future follow-up.

The type of endoscopic procedure should be recorded.

• Choose from one of the following:

• Endoscopic Resection (ER)

• Endoscopic Submucosal Dissection (ESD)

• Other (specify)

The Proceduralist’s opinion on the existence of local residual neoplasia following the operative procedure should be recorded.

• This item relates to the overall completeness of resection of the tumour, including evidence of residual disease at resection margins or within regions in which resection has not been attempted. It allows for residual tumour status (R) to be assessed.

Any previous pathological diagnosis should be recorded if known.

Any additional relevant information should be recorded.

• There should be a free text field so that the referring doctor can add anything that is not addressed by the above points, such as previous cancers, risk factors, investigations, treatments and family history.

57

Specimen handling

The specimen must be pinned out using stainless-steel pins along the periphery and fixed in 10% formalin (at least 10 volumes of formalin per approximate volume of specimen).

• This is best done in the procedure room following specimen retrieval. If not, the specimen should be sent fresh to the pathology department for immediate pinning and fixation.

The specimen must be capable of orientation if the status of specific margins is critical in determining the need for further resection or surgery and the extent required.

• Where orientation is required, the endoscopists should use the designation of O (oral) and A (anal) or P (proximal) /D (distal) marked on the board. This will allow the endoscopist to be informed of the area that may require further resection.

58

Example Request Information Sheet

The above Request Information Sheet is published to the RCPA website.

59

Appendix 2 Guidelines for formatting of a pathology report Layout

Headings and spaces should be used to indicate subsections of the report, and heading hierarchies should be used where the LIS allows it. Heading hierarchies may be defined by a combination of case, font size, style and, if necessary, indentation.

• Grouping like data elements under headings and using ‘white space’ assists in rapid transfer of information.37

Descriptive titles and headings should be consistent across the protocol, checklist and report.

When reporting on different tumour types, similar layout of headings and blocks of data should be used, and this layout should be maintained over time.

• Consistent positioning speeds data transfer and, over time, may reduce the need for field descriptions or headings, thus reducing unnecessary information or ‘clutter’.

Within any given subsection, information density should be optimised to assist in data assimilation and recall.

• Configuring reports in such a way that they ‘chunk’ data elements into a single unit will help to improve recall for the clinician.37

• ‘Clutter’ should be reduced to a minimum.37 Thus, information that is not part of the protocol (e.g. billing information, Snomed codes, etc) should not appear on the reports or should be minimized.

• Injudicious use of formatting elements (e.g. too much bold, underlining or use of footnotes) constitutes clutter and may distract the reader from the key information.

Where a structured report checklist is used as a template for the actual report, any values provided in the checklist but not applying to the case in question must be deleted from the formatted report.

Reports should be formatted with an understanding of the potential for the information to mutate or be degraded as the report is transferred from the LIS to other health information systems.

As a report is transferred between systems:

• text characteristics such as font type, size, bold, italics and colour are often lost

• tables are likely to be corrupted as vertical alignment of text is lost when fixed font widths of the LIS are rendered as proportional fonts on screen or in print

• spaces, tabs and blank lines may be stripped from the report, disrupting the formatting

• supplementary reports may merge into the initial report.

60

Appendix 3 Example of a pathology report

61

62

Appendix 4 WHO Classificationa of oesophageal tumours

Epithelial tumours Premalignant lesions Squamous

Intraepithelial neoplasia (dysplasia), low grade 8077/0* Intraepithelial neoplasia (dysplasia), high grade 8077/2

Glandular Dysplasia (intraepithelial neoplasia), low grade 8148/0* Dysplasia (intraepithelial neoplasia), high grade 8148/2

Carcinoma

Squamous cell carcinoma 8070/3 Adenocarcinoma 8140/3 Adenoid cystic carcinoma 8200/3 Adenosquamous carcinoma 8560/3 Basaloid squamous cell carcinoma 8083/3 Mucoepidermoid carcinoma 8430/3 Spindle cell (squamous) carcinoma 8074/3 Verrucous (squamous) carcinoma 8051/3 Undifferentiated carcinoma 8020/3

Neuroendocrine neoplasmsb

Neuroendocrine tumour (NET) NET G1 (carcinoid) 8240/3 NET G2 8249/3 Neuroendocrine carcinoma (NEC) 8246/3 Large cell NEC 8013/3 Small cell NEC 8041/3 Mixed adenoneuroendocrine carcinoma 8244/3

Mesenchymal tumours Granular cell tumour 9580/0 Haemangioma 9120/0 Leiomyoma 8890/0 Lipoma 8850/0 Gastrointestinal stromal tumour 8936/1 Kaposi sarcoma 9140/3 Leiomyosarcoma 8890/3 Melanoma 8720/3 Rhabdomyosarcoma 8900/3 Synovial sarcoma 9040/3

63

Lymphomas Secondary tumours

a The morphology code of the International Classification of Diseases for Oncology (ICD-O). Behaviour is coded /0 for benign tumours, /1 for unspecified, borderline or uncertain behaviour, /2 for carcinoma in situ and grade III intraepithelial neoplasia, and /3 for malignant tumours.

b The classification is modified from the previous (third) edition of the WHO classification of tumours taking into account changes in our understanding of those lesions. In the case of neuroendocrine neoplasms, the classification has been simplified to be of more practical utility in morphological classification.

* These new codes were approved by the IARC/WHO Committee for ICD-O at its meeting in March 2010.

64

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ENDOSCOPIC RESECTION (ER) OF THE OESOPHAGUS AND