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

Stopped early · Not applicable

Conditions studied: Cholangiocarcinoma, Stricture; Bile Duct

In brief

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.

Key facts

Study ID

NCT03211169

Run by

Stanford University

People needed

12

Starts

2017-07-29

Expected to finish

2019-09-01

Last updated by the study team

2019-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University Medical Center — Stanford, California, United States

Full record on ClinicalTrials.gov

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