Comparison Bile Duct Brushings, Cholangioscopy-Directed Biopsies and P

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

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https://clinicaltrials.gov/ct2/show/NCT03211169

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

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
Biopsies of the stricture will be taken to compare diagnostic yield of Pediatric Biopsy Forceps with biopsies taken under cholangioscopic guidance after bile duct brushings have been obtained.
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
Biopsies of the stricture will be taken to compare diagnostic yield of Pediatric Biopsy Forceps with biopsies taken under cholangioscopic guidance after bile duct brushings have been obtained.

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 5, 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:
Constriction, Pathologic
Cholangiocarcinoma
Pathological Conditions, Anatomical
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 07, 2017