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

NCT03211169 | Terminated

• 1 other identifier: 40988
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholangiocarcinoma; Stricture; Bile Duct

Outcome Measures

Primary Outcomes (1)

• Diagnostic tissue obtained as assessed by histologic evaluation of biopsy specimen

  Malignancy or no malignancy diagnosis obtained from stricture biopsy

  1 week

Secondary Outcomes (5)

• Cost

  2 years

• Radiation Exposure

  2 years

• Procedure Duration

  2 years

• Latency to diagnosis

  2 years

• Adverse Events

  2 weeks

Study Arms (2)

Pediatric Biopsy Forceps directed biopsies

EXPERIMENTAL

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

Cholangioscopy-directed biopsies

ACTIVE COMPARATOR

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

Interventions

Biopsies of bile duct stricture with pediatric biopsy forceps PROCEDURE

Biopsies of the stricture will be taken to evaluate diagnostic yield of Pediatric Biopsy Forceps

Pediatric Biopsy Forceps directed biopsies

Biopsies of bile duct stricture with cholangioscopy-directed biopsies PROCEDURE

Biopsies of the stricture will be taken to evaluate diagnostic yield of cholangioscopy-directed biopsies

Cholangioscopy-directed biopsies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Stanford University: lead
• University of Rochester: collaborator
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (1)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Cholangiocarcinoma; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Division of Gastroenterology

Model Details: Randomized prospective study

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 7, 2017
• Study Start: July 29, 2017
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: November 8, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)