pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture

Cholangiocarcinoma Clinical Trial

— FOCUS  

Official title:

pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01392274
• Other study ID #: MKT-2011-FOCUS
• Status: Completed
• Phase: N/A
• First received: July 7, 2011
• Last updated: December 2, 2014
• Start date: April 2012
• Est. completion date: September 2013

Study information

• Verified date: December 2014
• 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 SciencesItaly: Ethics Committee
• Study type: Observational

Clinical Trial Summary

This study will collect data from patients undergoing an ERCP procedure with probe-based Confocal Laser Endomicroscopy for suspicion of bile duct cancer. the objective is to evaluate the diagnostic performance of pCLE for the diagnosis of indeterminate biliary stricture when associated with other diagnostic information (standard ERCP and tissue sampling).

Description:

This trial aims at evaluating the performance diagnosis of pCLE for the detection of bile duct cancer, in patients with indeterminate biliary stricture when associated with other diagnostic information.

The hypothesis is that ERCP with Cellvizio probe-based endomicroscopy improves differentiation of biliary and pancreatic duct lesions versus ERCP alone or ERCP with tissue sampling, by improving the sensitivity of detection and by providing a real-time diagnosis.

Direct measures of accuracy (sensitivity, specificity, etc.) in the differentiation of malignant versus benign biliary duct lesions will be compared for the combination of ERCP alone, endomicroscopy plus ERCP imaging, and ERCP plus endomicroscopy plus tissue sampling. These information will be reviewed retrospectively by a second physician.

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 patient management recommendation. Yet, effective management recommendation is left as the discretion of the physician.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female > 18 years of age

• Indicated for ERCP for indeterminate bile duct stricture

• Referral patients with indeterminate biliary stricture coming in for first ERCP procedure at referral institution or

• Patients who had previous non-diagnostic tissue sampling (brushing biopsies or EUS-FNA) taken during a previous ERCP or EUS-FNA for an indeterminate biliary stricture

• Willing and able to comply with study procedures and provide written informed consent to participate in the study

Exclusion Criteria:

• Subjects for whom ERCP procedures are contraindicated

• Known allergy to fluorescein dye

• Patients suffering Primary Sclerosing Cholangitis or chronic pancreatitis.

• Patients with post-transplant stricture

• If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bile Duct Inflammation
• Cholangiocarcinoma
• Cholangitis
• Inflammation

Locations

Country	Name	City	State
France	Institut Paoli Calmettes	Marseille
Italy	Policlinico Univertitario Agostino Gemelli	Roma
United States	Yale new Haven Hospital	New Haven	Connecticut
United States	New York presbyterian Weill Cornell Medical center	New york	New York
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Mauna Kea Technologies

Countries where clinical trial is conducted

United States,  France,  Italy, 

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 l	Evaluation of pCLE diagnostic performance for the diagnosis of indeterminate biliary stricture (ie. number of patients accurately diagnosed) when associated with other diagnostic information The following calculations will be conducted: sensitivity, specificity, positive and negative predictive values, Accuracy	12 months	Yes
Secondary	Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious l		12 months follow-up	Yes