pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture (FOCUS)

Mauna Kea Technologies

Status: Completed

Conditions: Bile Duct Inflammation; Cholangiocarcinoma

Study type: Observational

Funder types: Industry

Identifiers

NCT01392274

MKT-2011-FOCUS

Details and patient eligibility

About

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).

Full 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.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

121 participants in 1 patient group

pCLE

Description:

This trial will study only one group which will receive a standard ERCP procedure followed by pCLE