Mid-Atlantic Research Group Single-Operator Cholangioscopic Assessment of Biliary Strictures

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mid-Atlantic Research Group Single-Operator Cholangioscopic Assessment of Biliary Strictures

Conditions
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Biliary Tract Neoplasms

Intervention / Treatment
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* Device: SOC-directed biopsies using the SpyGlass System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard<br>Standard of care biopsies with optional SOC-directed biopsy afterwards | |
| Experimental: Study<br>SOC-directed biopsies using the SpyGlass System plus standard of care biopsies | Device: SOC-directed biopsies using the SpyGlass System<br>* The cholangioscopy procedure with the SpyGlass System is performed by a single operator with the SpyScope Access and Delivery Catheter positioned just below the operating channel of the duodenoscope. SpyBite Biopsy Forceps guided by the SpyScope Catheter are introduced and endoscopic-guided biopsy is taken at the level of the stricture. Target lesions will be identified under direct visualization using the SOC system, and 6-8 bites will be performed with the SpyBite forceps. Once SOC-directed biopsies are obtained, the SOC system will be withdrawn into the working channel of the duodenoscope and removed Patient will be contacted monthly to determine if they have undergone any additional procedures and to record potential adverse events.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of malignant diagnoses across hree-sample techniques (Spy bite, forceps biopsy, brushings) | 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 | 72 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who receive additional diagnostic studies without receiving a cancer diagnosis | Patients who receive a repeat ERCP with sampling, cross-sectional imaging, EUS-FNA, IR-guided biopsies, laparoscopy | 1 year | 
| Endoscopic Satisfaction with SOC-directed biopsy | Endoscopist subjective outcomes using a Likert scale 1-5 Ease of obtaining the biopsies Confidence that the biopsy was taken from the target lesion Confidence that an adequate sample was obtained from the biopsy Clinical impression of malignant disease | 2 hours | 
| Time from procedure to the initiation of treatment (in cases of malignancy) |  | 1 year |