ANNUAL REPORT - EETC

1Fondazione Policlinico Universitario A. Gemelli IRCCS - Digestive Endoscopy Unit

REPORT 2018

2018ANNUAL REPORT

Fondazione Policlinico Universitario A. Gemelli IRCCS DIGESTIVE ENDOSCOPY UNIT


REPORT 2018

2 Fondazione Policlinico Universitario A. Gemelli IRCCS - Digestive Endoscopy Unit

REPORT 2018

PRESENTATION

Digestive Endoscopy has grown significantly in recent years. Today it plays a key role in the prevention, diagnosis and treatment of many digestive system diseases. It is enough to think of progress in prevention of colon cancer, early diagnosis of cancer of the entire digestive tract, the morphological and cyto-histological assessment of lesions accessible through the digestive tract under EUS guidance, treatment of many bilio-pancreatic diseases, endoscopic removal of superficial neoplastic lesions of the esophagus, stomach, small intestine and colon.The Digestive Endoscopy Unit of the Gemelli Hospital has grown substantially in recent years and it is now considered and recognized by all the major National and International Scientific Societies (WGO - World Gastroenterology Organiza-tion, WEO - World Endoscopy Organization, ESGE - European Society of Gastrointestinal Endoscopy, SIED - the Italian Society of Digestive Endoscopy), a centre of global excellence in clini-cal activity, research and training.In occasion of Endolive Roma 2019, we wanted to summarize all the activites produced in 2018. These results were achieved thanking to the team effort which involves: Doctors (staff members, Graduates, PhD students, Trainees at various levels and from all over the world), professional Nurses, all other Paramedical and Administrative Staff. All have supported the growth process of our structure in a consistent, dedicated, knowledgeable and enthusiastic way.

4 5Fondazione Policlinico Universitario A. Gemelli IRCCS - Digestive Endoscopy Unit

REPORT 2018

Fondazione Policlinico Universitario A. Gemelli IRCCS - Digestive Endoscopy Unit

REPORT 2018

NUMBER OF PROCEDURES CARRIED OUT IN 2018 AT THE GEMELLI HOSPITAL

1175ERCP

20ESOPHAGEAL

STENT

112ENDOSCOPIC

PNEUMATIC DILATATION

42ZENKER

SEPTOTOMY 19DUODENAL

STENT

85ENDOSCOPIC SLEEVE GASTROPLASTY (ESG)

65GASTRIC BYPASS

TRANSORAL OUTLET REDUCTION (TORe)

165PEG

8092GASTROSCOPY

9613COLONOSCOPY

111POEM

149VIDEOCAPSULE

ENDOSCOPY

2006EUS

26RFA OF BARRETT’S

ESOPHAGUS

635PHYSIOPATHOLOGY

378ADVANCED MUCOSAL

RESECTION

99SINGLE BALLON ENTEROSCOPY


REPORT 2018


REPORT 2018

TITLE OF THE TRIAL PROMOTER DESIGNRandomized Multi-Center Study Comparing No Drainage to Preoperative Biliary Drainage Using Metal Stents in Patients with Resectable Pancreatic or Periampullary Cancer Boston Scientific Corporation RCT (Medical device)

A Multi-Center, Prospective, Randomized Study Comparing Removable, Self-Expanding Metal Stents to Plastic Stents for the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis Boston Scientific Corporation RCT (Medical device)

Evaluation of Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes - Revita 2 C30000 Study Fractyl Laboratories Inc. RCT (Medical device)

A Multicenter Randomized Trial, Comparing EUS Fine Needle Biopsy (EUS-FNB) with Rapid on-Site Evaluation (ROSE) versus EUS-FNB Alone for the evaluation of Patients with Solid Pancreatic Lesions A.O.U.I. Verona - Gastroenterology and Digestive Endoscopy Unit RCT (Medical device)

Confronto tra coledocoduodenostomia ecoendoscopica guidata e CPRE con posizionamento di stent di metallo nei pazienti non operabili con stenosi neoplastica della via biliare principale: studio multcentrico randomiz-zato controllato FPG Digestive Endoscopy Unit RCT (Medical device)

A Phase II, multicentre, randomised, double-blind, placebo controlled, proof of concept study of efficacy and safety of Rifamycin SV-MMX® 600 mg tablets administered three or two times daily to patients with diarrhoea-predominant irritable bowel syndrome (IBS-D) Cosmo Technologies Ltd. RCT (Drug)

Pneumodilation Versus Per Oral Endoscopic Miotomy in Achalasia Patients with Recurrent Symptoms after Laparoscopic Heller Myotomy: The POEMA-2 Trial AMC UVA RCT (Endoscopic technique)

Miotomia Esofagea Transorale (POEM) nel trattamento dell’acalasia esofagea: miotomia lunga vs miotomia corta. Studio prospettico randomizzato UCSC Digestive Endoscopy Unit RCT (Endoscopic technique)

Fully Covered Self Expanding Metal Stents (FCSEMS) for Pancreatic Duct Strictures in Patients with Chronic Pancreatitis Boston Scientific Corporation Interventional (Medical Device)

Prospective, Confirmatory, Multicenter Study for the Evaluation of Safety and Performance of the Interscope EndoRotor® Endoscopic Mucosal Resection System for the Removal of Alimentary Tract Mucosa in the Colon Interscope Inc. Interventional (Medical Device)

Prospective study to evaluate partially covered SEMS in the treatment of esophageal acalasia UCSC Digestive Endoscopy Unit Interventional (Medical Device)

Pneumodilation Or Endoscopy Miotomy in Achalasia (POEMA) Trial AMC UVA Interventional (Endoscopic technique)

Sottoclassificazione molecolare del cancro del pancreas tramite biopsia tissutale Ecoendoscopica ai fini di una stratificazione prognostica e per una terapia individualizzata FPG Digestive Endoscopy Unit Interventional (Echoendoscopic technique)

EUS-guided laser complete ablation of advanced pancreatic ductal adenocarcinoma: a feasibility study FPG Digestive Endoscopy Unit Interventional (Echoendoscopic technique)

Safety and Efficacy of Endoscopic Ultrasound-guided RadioFrequency Ablation for the Treatment of Functional and non-functional Pancreatic NeuroEndocrine Neoplasms: A Multicenter Prospective Study FPG Digestive Endoscopy Unit Interventional (Echoendoscopic technique)

EPIC.net Italian Pancreas Studies Association Observational

Management of Direct Oral Anticoagulants (DOACs) for Elective GI Endoscopy Procedures: an Observational, Cross-sectional Study Como Valduce Hospital - Gastroenterology Unit Observational

The Quality Assessment in ERCP QUASIE2 Bucharest Colentina Clinical Hospital - Gastroenterology Division Observational

Studio prospettico osservazionale multicentrico sulla valutazione ecoendoscopica della via biliare in pazienti con ittero ostruttivo secondario a neoplasie maligne bilio-pancreatiche FPG Digestive Endoscopy Unit Observational

REte on QUality of ERCP, Endoscopy Services and Training Novara AOU Maggiore della Carità Registry

Italian Spyglass ERCP Registry Milan Humanitas Hospital Registry

A Worldwide Post-Market Surveillance Registry to assess the Medigus Ultrasonic Surgical Endostapler (MUSE™) System for the treatment of GERD Medigus Ltd. Registry

Trattamento endoscopico delle stenosi biliari non-anastomotiche post-trapianto di fegato. Registro della Società Italiana di Endoscopia Digestiva (STEBINANSIED) Società Italiana di Endoscopia Digestiva Registry

Comparazione delle performance degli aghi per biopsia con ago sottile ecoendoscopica FPG Digestive Endoscopy Unit Retrospective

Studio osservazionale retrospettivo sul trattamento endoscopico delle stenosi biliari non anastomotiche (ischemiche) dopo trapianto ortotopico di fegato: l’esperienza di un singolo centro FPG Digestive Endoscopy Unit Retrospective

Trattamento endoscopico Pancreatite Cronica UCSC Digestive Endoscopy Unit Retrospective

Studio Retrospettivo di analisi di sopravvivenza in pazienti sottoposti ad asportazione endoscopica di lesioni precancerose del tratto digestivo superiore in un singolo centro di endoscopia digestiva chirurgica di III UCSC Digestive Endoscopy Unit Retrospective

Comparison of needles performance for endoscopic ultrasound fine needle biopsy UCSC Digestive Endoscopy Unit Retrospective

STATUS OF CURRENT CLINICAL TRIALS


REPORT 2018


REPORT 2018

POST-GRADUATE SCHOOL OF GASTROENTEROLOGY AND DIGESTIVE ENDOSCOPY

The Complex Operative Digestive Endoscopy Unit is a part of the School of Specialization in Gastroenterology and Digestive Endoscopy of the Università Cattolica del Sacro Cuore. Prof. Costamagna, together with the Director of the Postgraduate School, Prof. Gasbarrini, provides a training course in Digestive Endoscopy which complies with Euro-pean Guidelines for Training in Digestive Gastroenterology (“Blue Book May 2012”) so that the specialist can use the title “Fellow of the European Board of Gastroenterology & Hepatology”.THE DURATION OF THE SCHOOL IS FOUR YEARS: TWO OF GENERAL TRAINING AND TWO OF SPECIALIST TRAINING.In collaboration with the unit of Internal Medicine and Gastroenterology, interns perform the Two-year period of general training in the dedicated Unit, while maintaining a strong propensity the management of internal medicine and gastroenterological and hepatological diseases. During the first two years the trainee, in addition to department management, it is required to attend surgeries such as gastroenterology hepatology, IBD, IBS, patients on transplant list and ultrasound.The next two years of Specialized Gastroenterological Training are purely dedicated to training in endoscopic proce-dures and gastroenterological diseases that can be treated endoscopically. The third year is dedicated to learning, with the supervision of a Tutor, the bases of diagnostic gastrointestinal endoscopy, colonoscopy and esophagogastro-duodenoscopy, with a progressive move towards autonomy. The fourth year sees the trainee involved in learning and performing independently therapeutic endoscopic procedures, with a progressive approach to endoscopic treatment of hepatobiliary diseases. Part of the training can be carried out in one of the many National and International struc-tures which our Unit is actively partnered with.From the third to fourth year all the interns are on-called for day and night endoscopic shifts for emergency endos-copy along with tenured Doctors.During the four years trainees are required to produce scientific research.In order to verify the achievement of the parameters required by the European guidelines, all activities carried out by the trainee during the four years must be certified by the compilation of a booklet.

PHD

PhD in Experimental Digestive Endoscopy, within the Graduate School in New Technologies in Diagnosis and Surgi-cal Therapy Specialist was established two years ago. The PhD program lasts three years and has four places, two with scholarship purse and two without. The aims of the PhD in Experimental Digestive Endoscopy are to prepare students in Experimental and Clinical Re-search, developing multidisciplinary relationships as much as possible, enabling students to be completely autono-mous in designing and carry out research projects.The research output of the current students is particularly numerous and at an international level.

TRAINEES IN 2018

3 RUSSIA

2 FRANCE

9 ITALY

1 SPAIN

2 GERMANY

1 CROATIA

1 ARGENTINA

1 CHILE

1 EGYPT

1 LUXEMBOURG

POST-GRADUATE TRAINING

Post-Graduate Training offers a variety of possibilities designed to give young doctors and nurses the necessary tools for professional growth within the Endoscopy area. All activities are organized by Prof. Costamagna, such as the Annual Master Degree, the hands-on courses organized at the EETC and Training Periods at the Digestive Endoscopy Unit


REPORT 2018


REPORT 2018

operating theater fully equipped with:

• 5 working station with state-of-the-art Olympus video-endoscopes, Erbe electrosurgical generators with Argon Plasma Coagulation, and medical gases

• Erlangen EASIE model• 4 mechanical simulators “Boškoski-

Costamagna ERCP Trainer”• Olympus Simulator

On the first floor are located:• A meeting room • A library• A room where catering can be

served • A classroom for 20-25 learners

equipped with a fully integrated audio-video system connected to the Endoscopy Unit ( Endoalfa - Olympus) that allows live broad-cast directly from the Endoscopy Unit to the EETC.

15 courses were organized at the European Endoscopy

Training Centre

EUROPEAN ENDOSCOPY TRAINING CENTRE (EETC)

The first structure in Europe to be exclusively dedicated to training in Digestive Endoscopy

The EETC was created in July 2003: the first structure in Europe to be exclusively dedicated to training in Digestive Endoscopy and one of the first in the world to have been purposed designed as such. It has already been recognised as an Official Training Centre by the European Society of Digestive Endoscopy (ESGE) and by the World Organisation in Gastroenterology and Endoscopy (WGO-WEO).The EETC was created at the Università Cattolica del Sacro Cuore di Roma thanks to the collaboration of five major International Biomedical Companies actively involved in field endoscopy: BARD, BOSTON SCIENTIFIC, WILSON COOK, ERBE and OLYMPUS.This has led to a concentration of cutting-edge technologies dedicated to the training of Italian and foreign gastroenterologists, endoscopists, surgeons in continuity with the training activity that for many years has been carried out at the Digestive Endoscopy

Unit of the Gemelli Hospital.The Theoretical and Practical Courses organized at the EETC cover a wide range of clinical and technical problems: upper digestive bleeding and gastro-oesophageal reflux disease treated endoscopically, esophageal, stomach and colon polypectomy and mucosectomy, herapeutic endoscopy treatment of the pancreas and biliary tract, small intestine and colon diagnosis and treatment with Traditional Endoscopy and Videocapsule.

The EETC collaborates with Biomedical Companies in order to organize courses or presentation on their latest devices or techniques.

The building has two floors extending over approximately 500 square meters. The heart of the EETC is situated at the basement floor where trainees can perform on animal models. There is an

27

2523

1817 17

15 1514

109

2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018


REPORT 2018


REPORT 2018

SOME PHOTOS OF 2018


REPORT 2018


REPORT 2018

2MODERATORS

27EXHIBITORS

29LOCAL FACULTY

6SPEAKERS

240 TOTAL BADGES FROM ITALY

TOTAL FACULTY

35TOTAL PARTICIPANTS

205

TOTAL REGITERED 240

ENDOCARE 2018Live Workshop for NursesEndocare is the first annual live video demonstration congress in the world fully dedicated to nurses.

The main objective is to up-to-date the participant’s skills in gastroenterology and digestive endoscopy with particular at-tention on patient care.

The importance of the doctor-nurse relationship is highlight-ed through discussion with expert, live procedures and practi-cal sessions.

Participants are able to assist the most advanced procedures through Live video demonstrations from the of Digestive En-doscopy Unit of the “Fondazione Policlinico Universitario A. Gemelli”. Learning continues through direct application on ex-vivo animal models and by using the “Boškoski-Costamagna mechanical simulator for CPRE” during the afternoon practical sessions at the European Endoscopy Training Centre.


REPORT 2018


REPORT 2018

425PHYSICIANS

53TRAINEES

120NURSE

PARTICIPANTS ENDOLIVE ROMA

2018

69LOCAL FACULTY

28MODERATORS

23SPEAKERS136

EXHIBITORS

SOME PHOTOS OF 2018


REPORT 2018

18 Fondazione Policlinico Universitario A. Gemelli IRCCS - Digestive Endoscopy Unit

REPORT 2018

ENDO LIVE ROMA IS A UNIQUE EDUCATIONAL EVENT,

ONE OF THE LEADING COURSES

IN TERMS OF QUALITY AND RELEVANCE

IN THE INTERNATIONAL ARENA, WITH THE PRESENCE

OF MORE THAN 854 PARTICIPANTS AND DELEGATIONS

FROM ALL CONTINENTS AND IN PARTICULAR

FROM 37 COUNTRIESMORE THAN 854 PARTICIPANTS

• Albania• Argentina• Australia• Austria• Belgium• Boznia• Brazil• Bulgaria• Canada• Chile• Croatia• Djibouti• Ecuador

• Estonia• France• Germany• Greece• Hungary• India• Italy• Japan• Lebanon• Lybia• Mexico• Montenegro• Poland

• Puerto Rico• Romania• Russian Federation• Serbia• Slovakia• Spain• Thailand• The Netherland• United Kingdom• United States of America• Uruguay


REPORT 2018


REPORT 2018

F.Ri.End ONLUS FOUNDATION

Digestive Endoscopy can treat numerous diseases of the digestive tract in a minimally invasive manner in order to reduce the risks connected to traditional surgery.

For many years now, the Digestive Endoscopy Unit - “Fondazione Policlinico Universitario A. Gemelli” Hospital, has been actively involved in the training of doctors from all over the World and officially recognized as Centre of Excellence from the major National and International Scientific Societies.

By training young endoscopists, it has been possible to outspread the most innovative diagnostic and therapeu-tic techniques in numerous Countries around the World.

Each year the Digestive Endoscopy Unit receives hun-dreds of training requests, most of them not adequately financially supported.

The aim of the F.Ri.End Foundation is to support train-ing for doctors from countries with a limited financial capacity.

FOR FURTHER INFORMATION ON HOW TO JOIN OUR MISSIONOR RECEIVE FURTHER INFORMATION

DO NOT HESITATE TO VISIT OUR WEBSITE

WWW.FRIENDONLUS.ORGOR CONTACT US AT [email protected]

POSTGRADUATE AWARDS IN MEMORY OF HIS EXCELLENCY MONSIGNOR ALESSANDRO PLOTTI

Digestive Endoscopy can treat numerous diseases of the digestive tract in a minimally invasive manner in order to reduce the risks connected to traditional surgery.For many years now, the Digestive Endoscopy Unit “A. Gemelli” Hospital, has been actively involved in the training of doctors from all over the World and officially recognized as Centre of Excellence from the major National and International Scientific Societies. By training young endoscopists, it has been possible to outspread the most innovative diagnostic and therapeutic techniques in numerous Countries around the World. Each year the Digestive Endoscopy Unit receives hundreds of training requests, most of them not adequately financially supported. The aim of the F.Ri.End Foundation is to support training for doctors from countries with a limited financial capacity.

BY TRAINING YOUNG ENDOSCOPISTS, IT HAS BEEN

POSSIBLE TO OUTSPREAD THE MOST INNOVATIVE

DIAGNOSTIC AND THERAPEUTIC TECHNIQUES

IN NUMEROUS COUNTRIES AROUND THE WORLD

FOR FURTHER INFORMATION

ON HOW TO JOIN OUR MISSION

OR RECEIVE FURTHER INFORMATION,

DO NOT HESITATE TO VISIT

OUR WEBSITE

WWW.FRIENDONLUS.ORG

OR CONTACT US AT

[email protected]

“During my training I have been observing a lot of procedures which are actually improving my training and will make me help many peo-ple in my country. As you know in Tanzania, we have very limited en-doscopy equipment as well as just a few people trained in endoscopy. I am looking forward going back to Tanzania, it will be very helpful for my coun-try. Thank you!”

Ezekiel Noah MoiranaArusha, Africa

“The main goal of my fellowship is to learn EUS and the Gemelli Hospital is one of its kind in Europe. The training will make me more confident and I

will be able to impart the same knowledge that I am going to acquire in EUS to my colleague when going back to my Centre in India.”

Shafiq SyedBengaluru, India


REPORT 2018


REPORT 2018

SOME PHOTOS OF 2018

Fondazione Policlinico Universitario A. Gemelli IRCCSDIGESTIVE ENDOSCOPY UNIT

Documents

ANNUAL REPORT - EETC