Clinical trial NCT02615210: Mid-Atlantic Research Group Single-Operator Cholangioscopic Assessment of Biliary Strictures
Official title: Mid-Atlantic Research Group Single-Operator Cholangioscopic Assessment of Biliary Strictures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Biliary Tract Neoplasms
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: Thomas Jefferson University
name: University of Pennsylvania
name: University of Pittsburgh Medical Center
name: Geisinger Clinic
name: McGill University Health Centre/Research Institute of the McGill University Health Centre
First posted: 2015-11-26
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if cholangioscopically-directed biopsies provide a higher diagnostic yield for malignancy in the setting of indeterminate biliary strictures when compared to standard means of sampling.

Detailed description: Biliary strictures in the absence of a mass are a clinical challenge, as current accepted means of sampling provide suboptimal accuracy. Both biliary brushings for cytology and fluoroscopically-directed biopsies produce highly-variable results. Endoscopic ultrasound with fine-needle aspiration has also been employed with variable results. An additional modality, using a single-operator cholangioscope during endoscopic retrograde cholangiopancreatography (ERCP) to obtain cholangioscopically-directed biopsies offers promise in increasing the yield of sampling. Initial observational studies have shown an improved diagnostic yield, but the technique has not been tested in a randomized, medical effectiveness study to better characterize its actual clinical impact. We aim to compare the technique of biopsy-on-biopsy derived sampling via single-operator cholangioscopy with standard fluoroscopically-directed biopsies and brushings in a pilot study. We also aim to perform a medical effectiveness study on the early use of single-operator cholangioscopically (SOC) in the evaluation of undiagnosed biliary strictures.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years
* Presence of indeterminate biliary strictures with clinical indications for ERCP. Strictures are considered indeterminate when evaluation including cross-sectional imaging is non-diagnostic. Patients who have previously undergone ERCP with sampling will be included, as well as those who have not previously undergone ERCP.
* Strictures located above the intrapancreatic bile duct
* The Subject's physician determines and ERCP is clinically indicated
* Able to provide informed consent

Exclusion Criteria:

* Prior enrollment in the study or another study evaluating biliary strictures
* Presence of extrahepatic malignancy or previously-diagnosed hepatocellular carcinoma
* Pregnancy
* At-risk populations including prisoners and mentally challenged
* Unwilling to provide informed consent
* Medically unfit to undergo ERCP
* History of liver transplant

Primary outcomes:
measure: Number of malignant diagnoses across hree-sample techniques (Spy bite, forceps biopsy, brushings)
timeFrame: 72 Hours
Secondary outcomes:
measure: Number of patients who receive additional diagnostic studies without receiving a cancer diagnosis
timeFrame: 1 year
measure: Endoscopic Satisfaction with SOC-directed biopsy
timeFrame: 2 hours
measure: Time from procedure to the initiation of treatment (in cases of malignancy)
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Temple University
name: Jennifre L Maranki, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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