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

Pancreatic Cancer Clinical Trial

Official title:

Endoscopic Retrograde CholangioPancreatography Endomicroscopy Registry Outcomes Database

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00779688
• Other study ID #: MKT-2008-ERCP-01
• Secondary ID: WIRB 20081709
• Status: Completed
• Phase: N/A
• First received: October 22, 2008
• Last updated: February 9, 2011
• Start date: November 2008
• Est. completion date: October 2010

Study information

• Verified date: February 2011
• Source: Mauna Kea Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardGermany: German Institute of Medical Documentation and InformationFrance: National Consultative Ethics Committee for Health and Life Sciences
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: October 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bile Duct Cancer
• Bile Duct Neoplasms
• Cholangiocarcinoma
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Institut Paoli-Calmettes	Marseilles
Germany	Klinikum rechts der Isar	Munich	Bayern
United States	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

Sponsors (3)

Lead Sponsor	Collaborator
Mauna Kea Technologies	Cellvizio Inc., Emissary International LLC

Countries where clinical trial is conducted

United States,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious lesions.		12-month diagnostic follow-up confirmation	Yes