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

Comparative Efficacy of Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies for Obtaining Diagnostic Tissue From Indeterminate Biliary Strictures

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.

Study Overview

• Status: Terminated
• Conditions: Cholangiocarcinoma; Stricture; Bile Duct
• Intervention / Treatment: Procedure: Biopsies of bile duct stricture with pediatric biopsy forceps; Procedure: Biopsies of bile duct stricture with cholangioscopy-directed biopsies

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic tissue obtained as assessed by histologic evaluation of biopsy specimen	Malignancy or no malignancy diagnosis obtained from stricture biopsy	1 week

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: The University of Texas Health Science Center, Houston; University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2017
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (Actual): July 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 8, 2019
• Last Update Submitted That Met QC Criteria: November 6, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Constriction, Pathologic; Cholangiocarcinoma
• Other Study ID Numbers: 40988

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No