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

Stanford University

Status: Terminated

Conditions: Stricture; Bile Duct; Cholangiocarcinoma

Treatments: Procedure: Biopsies of bile duct stricture with cholangioscopy-directed biopsies; Procedure: Biopsies of bile duct stricture with pediatric biopsy forceps

Study type: Interventional

Funder types: Other

Identifiers

NCT03211169

40988

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Pediatric Biopsy Forceps directed biopsies

Experimental group

Description:

Biopsies of the stricture will be taken with Pediatric Biopsy Forceps after bile duct brushings have been obtained.

Treatment:

Procedure: Biopsies of bile duct stricture with pediatric biopsy forceps

Cholangioscopy-directed biopsies

Active Comparator group

Description:

Biopsies of the stricture will be taken under cholangioscopic guidance after bile duct brushings have been obtained.

Treatment:

Procedure: Biopsies of bile duct stricture with cholangioscopy-directed biopsies