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

Not Applicable

Terminated

• Conditions: Cholangiocarcinoma; Stricture; Bile Duct
• Interventions: Procedure: Biopsies of bile duct stricture with pediatric biopsy forceps; Procedure: Biopsies of bile duct stricture with cholangioscopy-directed biopsies

• Registration Number: NCT03211169
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-30
• Study First Submitted QC: 2017-07-05
• Study First Posted: 2017-07-07
• Study Start: 2017-07-29
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-06
• Last Update Posted: 2019-11-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. All patients with obstructive jaundice, and imaging (CT or MRI) suggestive of biliary stricture, without obvious pancreatic mass
2. All patients with obstructive jaundice, and index ERCP suggestive of biliary stricture, without obvious pancreatic mass
3. All patients with obstructive jaundice, and prior ERCP suggestive of biliary stricture
4. Expected patient survival of at least 90 days
5. High likelihood of patient follow-up
6. Patient is able to give a written informed consent
7. Patient is willing and able to comply with the study procedures

Exclusion Criteria

1. Patients with imaging suggestive of pancreatic tumor
2. Children < 18 years of age
3. Pregnant women
4. Patients with impaired decision-making
5. Healthy volunteers
6. Primary Sclerosing Cholangitis (PSC)
7. Patients with untreated coagulopathy at the time of procedure or ongoing need for anti-coagulation
8. Patients with any contraindication to endoscopic procedure
9. Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
10. Patients unable to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pediatric Biopsy Forceps directed biopsies	Biopsies of bile duct stricture with pediatric biopsy forceps	Biopsies of the stricture will be taken with Pediatric Biopsy Forceps after bile duct brushings have been obtained.
Cholangioscopy-directed biopsies	Biopsies of bile duct stricture with cholangioscopy-directed biopsies	Biopsies of the stricture will be taken under cholangioscopic guidance after bile duct brushings have been obtained.

Primary Outcome Measures

Name	Time	Method
Diagnostic tissue obtained as assessed by histologic evaluation of biopsy specimen	1 week	Malignancy or no malignancy diagnosis obtained from stricture biopsy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Stanford University Medical Center; 🇺🇸 Stanford, California, United States