Clinical trial NCT01392274: pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture
Official title: pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholangiocarcinoma
Bile Duct Inflammation
Lead sponsor: Mauna Kea Technologies
Sponsor class: INDUSTRY
First posted: 2011-07-12
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Bile Duct Cancers

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious l
timeFrame: 12 months
Secondary outcomes:
measure: Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious l
timeFrame: 12 months follow-up
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale new Haven Hospital
state: Connecticut
city: New york
country: United States
facility: New York presbyterian Weill Cornell Medical center
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Roma
country: Italy
facility: Policlinico Univertitario Agostino Gemelli
Study officials:
affiliation: University of Pittsburh Medical Center
name: Adam Slivka, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Slivka A, Gan I, Jamidar P, Costamagna G, Cesaro P, Giovannini M, Caillol F, Kahaleh M. Validation of the diagnostic accuracy of probe-based confocal laser endomicroscopy for the characterization of indeterminate biliary strictures: results of a prospective multicenter international study. Gastrointest Endosc. 2015 Feb;81(2):282-90. doi: 10.1016/j.gie.2014.10.009.