A Registry of Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Pancreatic and Bile Duct Cancers

Sponsor

Mauna Kea Technologies (Industry)

Overall Status

Completed

CT.gov ID

NCT00779688

Collaborator

Cellvizio Inc. (Industry), Emissary International LLC (Industry)

130

Enrollment

Locations

Duration (Months)

21.7

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This registry will collect data from patients routinely undergoing an ERCP and Cellvizio endomicroscopy procedure (and optionally an additional cholangiopancreatoscopy procedure) due to suspected pancreatic or bile duct cancer. The objective is to determine if endomicroscopy images collected using the marketed Cellvizio device may help endoscopists more accurately diagnose, in conjunction with traditional tissue sampling techniques, whether a suspected lesion is malignant or benign.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Bile Duct Cancer	Device: Probe-based confocal laser endomicroscopy

Detailed Description

This is a registry study to collect high quality longitudinal data from patients with suspected or indeterminate pancreaticobiliary pathology who are undergoing an ERCP with Cellvizio probe-based endomicroscopy procedure, with or without supplemental direct cholangiopancreatoscopy. The hypothesis is that ERCP with Cellvizio probe-based endomicroscopy improves differentiation of biliary and pancreatic duct lesions versus ERCP alone.

Direct measures of accuracy (sensitivity, specificity, etc.) in the differentiation of malignant versus benign biliary and/or pancreatic duct lesions will be compared for the combination of endomicroscopy and ERCP imaging and ERCP alone. These presumptive diagnoses will be compared against a 12-month follow-up confirmed histopathologic endpoint (an initially-benign pathologic diagnosis will be confirmed by a 12-month follow-up). Secondary objectives include collecting various safety and technical performance parameters.

Study Design

Study Type:

Observational

Actual Enrollment :

130 participants

Time Perspective:

Prospective

Official Title:

Endoscopic Retrograde CholangioPancreatography Endomicroscopy Registry Outcomes Database

Study Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Oct 1, 2010

Outcome Measures

Primary Outcome Measures

Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious lesions. [12-month diagnostic follow-up confirmation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female > 18 years of age
Willing and able to comply with Registry procedures and provide written informed consent to participate in the Registry
Indicated for ERCP and/or cholangiopancreatoscopy
Indeterminate or suspected biliary and/or pancreatic stricture, mass, or neoplasm

Exclusion Criteria:

Subjects for whom ERCP procedures are contraindicated
Known allergy to fluorescein dye

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Hospital	Aurora	Colorado	United States	80045
2	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
3	New York Presbyterian Hospital/Columbia University Medical Center	New York	New York	United States	10032
4	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
5	Institut Paoli-Calmettes	Marseilles		France	13273
6	Klinikum rechts der Isar	Munich	Bayern	Germany	81675