Comparison Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies in Biliary Strictures

Study Overview
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Brief Summary
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Prospective, randomized, multi-center study. Investigators will compare diagnostic yield of bile duct brushings, pediatric biopsy forceps biopsies and cholangioscopy-directed biopsies for obtaining diagnostic tissue from biliary strictures.

Official Title
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Comparative Efficacy of Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies for Obtaining Diagnostic Tissue From Indeterminate Biliary Strictures

Conditions
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Cholangiocarcinoma, Stricture; Bile Duct

Intervention / Treatment
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* Procedure: Biopsies of bile duct stricture with pediatric biopsy forceps
* Procedure: Biopsies of bile duct stricture with cholangioscopy-directed biopsies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with obstructive jaundice, and imaging (CT or MRI) suggestive of biliary stricture, without obvious pancreatic mass All patients with obstructive jaundice, and index ERCP suggestive of biliary stricture, without obvious pancreatic mass All patients with obstructive jaundice, and prior ERCP suggestive of biliary stricture Expected patient survival of at least 90 days High likelihood of patient follow-up Patient is able to give a written informed consent Patient is willing and able to comply with the study procedures Exclusion Criteria: Patients with imaging suggestive of pancreatic tumor Children < 18 years of age Pregnant women Patients with impaired decision-making Healthy volunteers Primary Sclerosing Cholangitis (PSC) Patients with untreated coagulopathy at the time of procedure or ongoing need for anti-coagulation Patients with any contraindication to endoscopic procedure Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit Patients unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: Randomized prospective study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pediatric Biopsy Forceps directed biopsies<br>Biopsies of the stricture will be taken with Pediatric Biopsy Forceps after bile duct brushings have been obtained. | Procedure: Biopsies of bile duct stricture with pediatric biopsy forceps<br>* Biopsies of the stricture will be taken to evaluate diagnostic yield of Pediatric Biopsy Forceps<br>|
| Active Comparator: Cholangioscopy-directed biopsies<br>Biopsies of the stricture will be taken under cholangioscopic guidance after bile duct brushings have been obtained. | Procedure: Biopsies of bile duct stricture with cholangioscopy-directed biopsies<br>* Biopsies of the stricture will be taken to evaluate diagnostic yield of cholangioscopy-directed biopsies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic tissue obtained as assessed by histologic evaluation of biopsy specimen | Malignancy or no malignancy diagnosis obtained from stricture biopsy | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost | Cumulative $ from devices used and facility fees with each approach | 2 years | 
| Radiation Exposure | Total Dose, Fluoroscopy Time, Dose Area Product, Effective dose per fluoroscopy machine readings | 2 years | 
| Procedure Duration | in minutes | 2 years | 
| Latency to diagnosis | Duration in days from initial procedure to diagnosis of benign or malignant stricture | 2 years | 
| Adverse Events | (Pancreatitis, Bleeding, Infection, Perforation, Death to be assessed one day, one week post-procedure | 2 weeks |