Mid-Atlantic Research Group Single-Operator Cholangioscopic Assessment of Biliary Strictures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Temple University
- Enrollment
- 3
- Primary Endpoint
- Number of malignant diagnoses across hree-sample techniques (Spy bite, forceps biopsy, brushings)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Number of malignant diagnoses across hree-sample techniques (Spy bite, forceps biopsy, brushings)
Time Frame: 72 Hours
Accuracy, sensitivity, and specificity of the three-sample technique (Spy bite, forceps biopsy, brushings) compared to the two-sample technique (forceps biopsy and brushing) in differentiating malignant from benign biliary strictures
Secondary Outcomes
- Number of patients who receive additional diagnostic studies without receiving a cancer diagnosis(1 year)
- Endoscopic Satisfaction with SOC-directed biopsy(2 hours)
- Time from procedure to the initiation of treatment (in cases of malignancy)(1 year)