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GASTROENTEROLOGY
SEE CLEARLY, ACT FASTER
CONFOCAL LASER ENDOMICROSCOPY (CLE)
HD White Light Endoscopy
X 30 MACROSCOPIC
ANALYSIS
HistologyBIOPSY: MICROSCOPIC
ANALYSIS
Cellvizio X 1000
ENDOMICROSCOPIC ANALYSIS
Cellvizio MINIPROBELIVE
Cellvizio provides real-time vision at the cellular level
-
1. Brugge W. et al. Diagnosis of Pancreatic Cystic Neoplasms: A
Report of the Cooperative Pancreatic Cyst Study, Gastroenterology,
2004. 2. Jais B. et al. Serous cystic neoplasm of the pancreas: a
multinational study of 2622 patients under the auspices of the
International Association of Pancreatology and European Pancreatic
Club (European Study Group on Cystic Tumors of the Pancreas). Gut
2015. 3. Konda VJA, et al. A pilot study of in vivo identification
of pancreatic cystic neoplasms with needle-based confocal laser
endomicroscoscopy under endosonographic guidance. Endoscopy,
2013.(INSPECT) 4. Nakai Y, et al. Diagnosis of pancreatic cysts:
EUS-guided, through-the-needle confocal laser-induced
endomicroscopy and cystoscopy trial: DETECT study. Gastrointestinal
Endoscopy, 2015. 5.!Napoléon B, et al. In vivo characterization of
pancreatic cysts lesions by needle-based confocal laser
endomicroscopy (nCLE): proposition of a comprehensive nCLE
classification confirmed by an external retroscpective evaluation.
Surg Endos. 2015. (CONTACT 1)
PANCREATIC CYSTS
1 out of 5 cysts remains indeterminate after EUS1
Mucinous cysts can be confirmed with very high specificity in
about 7 out of 10 cases3,4
The Papillary Projection criterion in an IPMN3
Serous cystadenoma can be confirmed with very high specificity
in 7 out of 10 cases5
Compatible operating channel Length Maximum # of uses Field of
view Resolution Confocal depth
≥ 0.91 mm 4 m 10 Ø 325 µm 3.5 µm 40 to 70 µm
The Superficial Vascular Network criterion in a Serous
Cystadenoma5
º Confirm the EUS impression, when cytological confirmation is
missing3-5
º Improve characterization for indeterminate cysts3-5
Clinical studies have shown that nCLE provides on-the-spot
characterization of various types of cysts
AQ-Flex™ 19 Miniprobe
CONSEQUENCE º 4 out of 10 patients with benign pancreatic
cysts undergo unnecessary surgery due to uncertain
diagnoses2
º Repeat EUS-FNA procedures are required
50%+1/5Over 50% of cysts are missing cytological
confirmation1
Cytology misses half of the mucinous cysts, and CEA levels
overlap yielding unspecific result1
Sen
siti
vity
59-7
7%
Sp
ecifi
city
100
%
Sen
siti
vity
69%
Sp
ecifi
city
100
%
INSPECT study, 65 patients, multi-centric3 DETECT study, 30
patients, mono-centric4
Cleared intended use: The Cellvizio® 100 Series System with
Confocal Miniprobes™ is a confocal laser system with fiber optic
probes that is intended to allow imaging of the internal
microstructure of tissues in anatomical tracts, i.e.,
gastrointestinal. The AQ-Flex 19™, member of the GastroFlex M™
series of Confocal Miniprobes, can be used within anatomical
tracts, i.e., gastrointestinal, accessed by an endoscope or
endoscopic accessories, including through EUS-FNA needles.
CONTACT 1 study, 33 patients, multi-centric5
(19G EUS-FNA needle)
THE CELLVIZIO SOLUTION ADDING nCLE TO STANDARD PRACTICE CAN
HELP:
-
6. Slivka A. et al. Validation of the diagnostic accuracy of
probe-based confocal laser endomicroscopy for the characterization
of indeterminate biliary strictures: results of a prospective
multicenter international study, Gastrointestinal Endoscopy,
2015.(FOCUS) 7. Shah RJ et al. Cholangioscopy and cholangioscopic
forceps biopsy in patients with indeterminate pancreaticobiliary
pathology. Clinical Gastroenterology and Hepatology, 2006. 8.
Gerhards MF et al. Incidence of benign lesions in patients resected
for suspicious hilar obstruction. Br J Surg, 2001. 9. Varadarajulu
S. et al. The role of endoscopic ultrasonography in the evaluation
of pancreatico-biliary cancer. Surg Clin North Am, 2010. 10.
Meining A. et al. Direct Visualization of Indeterminate
Pancreaticobiliary Strictures using Probe-based Confocal Laser
Endomicroscopy - A Multicenter Experience. Gastrointestinal
Endoscopy, 2011.
BILIARY STRICTURES
Over 60% of patients remain histologically indeterminate after
ERCP6
Inflammatory stricture10
Malignant stricture6
Compatible operating channel Length Maximum # of uses Field of
view Resolution Confocal depth
≥ 1.0 mm 4 m 10 Ø 325 µm 3.5 µm 40 to 70 µm
º Rule out cancer with more confidence for strictures that
appear benign6
º Document a malignant ERCP impression, when tissue sampling
comes back indeterminate6
CholangioFlex™ Miniprobe
CONSEQUENCE º Up to 3 ERCP procedures may be required
to obtain a diagnosis7
º 15-24% of surgical resections for suspected biliary malignancy
reveal benign etiologies8,9
60%+
15-24% benign etiology
after surgery
NPV of ERCP with tissue sampling
and pCLENPV of ERCP with tissue sampling
82% 73% Sensitivity of ERCP with tissue sampling
and pCLESensitivity of tissue sampling alone
89% 56%
Clinical studies have shown that pCLE reduces the number of
patients with indeterminate strictures after ERCP6
Cleared intended use: The Cellvizio® 100 Series System with
CholangioFlex™ (GastroFlex M™) is a confocal laser system with
fiber optic probes that is intended to allow imaging of the
internal microstructure of tissues in the upper gastrointestinal
tract including biliary and pancreatic ducts, accessed by an
endoscope or endoscopic accessories.
FOCUS study, 112 patients, multi-centric6
x3ERCP
THE CELLVIZIO SOLUTION ADDING pCLE TO STANDARD PRACTICE CAN
HELP:
-
15. M. Canto, et al. In vivo endomicroscopy improves detection
of Barrett’s esophagus–related neoplasia: a multicenter
international randomized controlled trial, GIE 2013. 16. Sharma P.
et al. Real-time Increased Detection of Neoplastic Tissue in
Barrett’s Esophagus with probe- based Confocal Laser
Endomicroscopy: Final Results of a Multi-center Prospective
International Randomized Controlled Trial. Gastrointestinal
Endoscopy, 2011 (DONT BIOPCE). 17. Konda V.J. et al. Confocal laser
endomicroscopy: potential in the management of Barrett’s esophagus.
Diseases of the Esophagus, 2010. 18. Bertani H. et al. Improved
Detection of Incident Dysplasia by pCLE in a BE Surveillance
Program. Dig Dis Sci, 2013.
BARRETT’S ESOPHAGUS
Inefficient random sampling with a low diagnostic yield at
6%15
Intestinal metaplasia16 Dysplasia16
Biopsies can be avoided for 60% of patients18 (When WLE, NBI and
pCLE all look normal)
Compatible operating channel Length Maximum # of uses Field of
view Resolution Confocal depth
≥ 2.8 mm 3 m 20 Ø 240 µm 1 µm 55 to 65 µm
º Reduce the number of biopsies needed while increasing
diagnostic yield15-16
º Map an area prior to treatment and evaluate the completeness
of treatment upon follow up17
GastroFlex™ UHD Miniprobe
CONSEQUENCE º Increased patient anxiety & procedural costs º
Treatment delay º Recurrence and residual dysplasia
6% yield ?Limited insight on the choice of treatment modality
and on the completeness of treatment
Sensitivity of pCLE with WLE or NBI
Sensitivity of WLE or NBI
76% 45%Sensitivity of pCLE
with WLESensitivity of WLE alone
68% 34%
Clinical studies have shown that pCLE increases the diagnostic
yield of procedures
Cleared intended use: The Cellvizio® 100 Series System with
GastroFlex UHD™ is a confocal laser system with fiber optic probes
that is intended to allow imaging of the internal microstructure of
tissues in anatomical tracts, i.e., gastrointestinal, accessed by
an endoscope or endoscopic accessories.
DONT BIOPCE study, 101 patients, multi-centric16
60%
THE CELLVIZIO SOLUTION ADDING pCLE TO STANDARD PRACTICE CAN
HELP:
-
11. Shahid M.W. et al. Diagnostic Accuracy of probe based
Confocal Laser Endomicroscopy in Detecting Residual Colorectal
Neoplasia after EMR: A prospective Study. Gastrointestinal
Endoscopy, 2012. 12. Wallace et al. Miami classification for pCLE.
Endoscopy, 2011. 13. Kiesslich R. et al. Local Barrier Dysfunction
Identified by Confocal Laser Endomicroscopy Predicts Relapse in
Inflammatory Bowel Disease. Gut, 2012. 14. Neuman H. et al.
Endoscopy and Endocytoscopy in IBD. Gastrointest Endosc Clin Am,
2013.
COLORECTAL LESIONS AND IBD
25% of patients with colorectal lesions show residual or
recurring neoplasia at follow-up post EMR11
Hyperplastic polyp12 Adenocarcinoma12
Compatible operating channel Length Maximum # of uses Field of
view Resolution Confocal depth
≥ 2.8 mm 4 m 20 Ø 240 µm 1 µm 55 to 65 µm
º Assess in real-time the extent of a flat lesion, allowing
immediate and complete endoscopic resection in a single
procedure11
º Assess the disease state at the mucosal level (remission,
relapse) and adapt treatment immediately13-14
ColoFlex™ UHD Miniprobe
CONSEQUENCE º Patients must await results of follow-up
biopsies before potentially returning for additional EMR if
needed
º Increased medication, pain and anxiety for the patient
25% Drugs prescription and dosageDrugs for inflammatory bowel
diseases are prescribed and escalated based on symptoms only but
the dosage is hard to adapt on symptoms alone13
Sensitivity of pCLE with HRE-VCE
Sensitivity of High-Resolution Endoscopy with Virtual
Chromoendoscopy (HRE-VCE)
100% 72%NPV of pCLE
with HRE-VCE NPV of HRE-VCE
100% 91%
Clinical studies on colorectal lesions have shown that pCLE
increases the diagnostic yield of your procedure
Cleared intended use: The Cellvizio® 100 Series System with
ColoFlex UHD™ is a confocal laser system with fiber optic probes
that is intended to allow imaging of the internal microstructure of
tissues in anatomical tracts, i.e., gastrointestinal, accessed by
an endoscope or endoscopic accessories.
Shahid et al., 92 patients, multi-centric11
THE CELLVIZIO SOLUTION ADDING pCLE TO STANDARD PRACTICE CAN
HELP:
-
EUROPEMauna Kea Technologies SA 9, rue d’Enghien75010 Paris,
FranceTel : + 33 1 48 24 03 45 Fax : +33 1 48 24 12 18
450 40 800+Cellvizio installed…
CELLVIZIO WORLDWIDE
Cellvizio® in Gastroenterology Cellvizio® Academy
…in more than forty countries Peer reviewed publications on
endomicroscopy
º A dedicated training website: cellvizio.net
º Educational events around the world, led by endomicroscopy
experts
NORTH AMERICAMauna Kea Technologies, Inc. 185 Alewife Brook
Parkway, Suite 215Cambridge, MA 02138,Tel : +1 (678) 731 7544Fax :
+1 (888) 797 6640Toll free : + 1 (888) 590 1798
ASIAMauna Kea Technologies China Office 30, 26F, Tengfei
PlazaNo. 333 Tianyaoqiao Rd,Xuhui District, Shanhai, China
CELLVIZIO.NET
MAUNAKEATECH.COM [email protected]
18. Li Y.Q. et al. New Classification of Gastric Pit Patterns
and Vessel Architecture Using Probe-based Confocal Laser
Endomicroscopy. J Clin Gastroenterol, 2015. Cellv
izio
GI B
roch
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INT
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, v1.0
1
The Cellvizio® Systems are regulated Medical Device, CE marked
(Class IIa - NB : LNE/G-MED) and FDA cleared; Cellvizio systems are
intended to allow confocal laser imaging of the internal
microstructure of tissues in anatomical tracts, i.e.
gastrointestinal, respiratory or urinary, accessed through an
endoscope or endoscopic accessories. These statements and the
associated references to specific clinical studies, are not
intended to represent claims of safety or effectiveness for
detecting or treating any specific condition or disease state.
Rather this information is intended to provide useful reference to
selected published literature describing physician experiences with
the associated clinical uses. These statements have not been
reviewed, cleared, or approved by the U.S. FDA. Please note that
the interpretation criteria are suggested descriptive features and
do not represent definitive diagnostic landmarks and are a result
of input from trained and well qualified person. Any diagnostic
assessment should always be made by the attending physician, based
on the evaluation of all sources of clinical, endoscopic and other
relevant information. Please consult labels and instructions for
use.
Barrett’s esophagus
Bilio-pancreatic strictures
Pancreatic cysts Colorectal lesions
Inflammatory bowel diseases
Gastric lesions18
150 200 100
