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

This study is not yet open for participant recruitment.

See

Contacts and Locations

Verified July 2017 by Subhas Banerjee, Stanford University

Sponsor:

Collaborators:

University of Rochester

The University of Texas Health Science Center, Houston

Information provided by (Responsible Party):

Subhas Banerjee, Stanford University

ClinicalTrials.gov Identifier:

NCT03211169

First received: June 30, 2017

Last updated: July 6, 2017

Last verified: July 2017

History of Changes

Purpose

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.

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Randomized prospective study Masking: No masking Primary Purpose: Diagnostic
Official Title:	Comparative Efficacy of Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies for Obtaining Diagnostic Tissue From Indeterminate Biliary Strictures

Resource links provided by NLM:

Genetics Home Reference related topics: cholangiocarcinoma

MedlinePlus related topics: Biopsy

U.S. FDA Resources

Further study details as provided by Subhas Banerjee, Stanford University:

Primary Outcome Measures:

Diagnostic tissue obtained as assessed by histologic evaluation of biopsy specimen [ Time Frame: 1 week ]
Malignancy or no malignancy diagnosis obtained from stricture biopsy

Secondary Outcome Measures:

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


Estimated Enrollment:	100
Anticipated Study Start Date:	July 15, 2017
Estimated Study Completion Date:	July 1, 2020
Estimated Primary Completion Date:	July 1, 2020 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pediatric Biopsy Forceps directed biopsies 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 Biopsies of the stricture will be taken to evaluate diagnostic yield of Pediatric Biopsy Forceps
Active Comparator: Cholangioscopy-directed biopsies 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 Biopsies of the stricture will be taken to evaluate diagnostic yield of cholangioscopy-directed biopsies

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03211169

Contacts


Contact: Subhas Banerjee, MD	650-723-2623	sbanerje@stanford.edu

Sponsors and Collaborators

Stanford University

University of Rochester

The University of Texas Health Science Center, Houston

More Information


Responsible Party:	Subhas Banerjee, Associate Professor of Medicine, Division of Gastroenterology, Stanford University
ClinicalTrials.gov Identifier:	NCT03211169 History of Changes
Other Study ID Numbers:	40988
Study First Received:	June 30, 2017
Last Updated:	July 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:


Cholangiocarcinoma Constriction, Pathologic Adenocarcinoma Carcinoma	Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 11, 2017

To Top