NCT00779688

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

Endoscopic Retrograde CholangioPancreatography Endomicroscopy Registry Outcomes Database

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 130 (actual)
• Sponsor: Mauna Kea Technologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer
• Bile Duct Cancer

Interventions

Type	Name	Description
DEVICE	Probe-based confocal laser endomicroscopy	ERCP with or without cholangiopancreatoscopy will be performed by the endoscopist as clinically indicated. If findings at ERCP and/or prior imaging studies and/or clinical assessment suggest possible malignancy and/or an indeterminate biliary or pancreatic pathology Cellvizio probe-based endomicroscopy will be performed during ERCP.

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-09-01
• Completion: 2010-10-01
• First posted: 2008-10-24
• Last updated: 2011-02-10

Locations

6 sites across 3 countries: United States, France, Germany