Mid-Atlantic Research Group Single-Operator Cholangioscopic Assessment of Biliary Strictures (SOCABS)
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About
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.
Full 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.
Enrollment
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
3 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Jennifer Maranki, M.D.
Data sourced from clinicaltrials.gov
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