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

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ClinicalTrials.gov Identifier: NCT03211169
Recruitment Status : Recruiting
First Posted : July 7, 2017
Last Update Posted : September 11, 2018
Sponsor:
Collaborators:
University of Rochester
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Subhas Banerjee, Stanford University

Tracking Information
First Submitted Date  ICMJE June 30, 2017
First Posted Date  ICMJE July 7, 2017
Last Update Posted Date September 11, 2018
Actual Study Start Date  ICMJE July 29, 2017
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2017)
Diagnostic tissue obtained as assessed by histologic evaluation of biopsy specimen [ Time Frame: 1 week ]
Malignancy or no malignancy diagnosis obtained from stricture biopsy
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03211169 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies in Biliary Strictures
Official Title  ICMJE Comparative Efficacy of Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies for Obtaining Diagnostic Tissue From Indeterminate Biliary Strictures
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized prospective study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Cholangiocarcinoma
  • Stricture; Bile Duct
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Pediatric Biopsy Forceps directed biopsies
    Biopsies of the stricture will be taken with Pediatric Biopsy Forceps after bile duct brushings have been obtained.
    Intervention: Procedure: Biopsies of bile duct stricture with 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.
    Intervention: Procedure: Biopsies of bile duct stricture with cholangioscopy-directed biopsies
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 5, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2020
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Subhas Banerjee, MD 650-723-2623 sbanerje@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03211169
Other Study ID Numbers  ICMJE 40988
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Subhas Banerjee, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE
  • University of Rochester
  • The University of Texas Health Science Center, Houston
Investigators  ICMJE Not Provided
PRS Account Stanford University
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP