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

Completed

• Conditions: Pancreatic Cancer; Bile Duct Cancer

• Registration Number: NCT00779688
• Lead Sponsor: Mauna Kea Technologies

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.

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 Timeline

• Study First Submitted: 2008-10-22
• Study First Submitted QC: 2008-10-23
• Study First Posted: 2008-10-24
• Study Start: 2008-11
• Primary Completion: 2009-09
• Study Completion: 2010-10
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-09
• Last Update Posted: 2011-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (6)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

New York Presbyterian Hospital/Columbia University Medical Center; 🇺🇸 New York, New York, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Institut Paoli-Calmettes; 🇫🇷 Marseilles, France

Klinikum rechts der Isar; 🇩🇪 Munich, Bayern, Germany