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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

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.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Stricture; Bile Duct Procedure: Biopsies of bile duct stricture with pediatric biopsy forceps Procedure: Biopsies of bile duct stricture with cholangioscopy-directed biopsies Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized prospective study
Masking: None (Open Label)
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
Actual Study Start Date : July 29, 2017
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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




Primary Outcome Measures :
  1. 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 :
  1. Cost [ Time Frame: 2 years ]
    Cumulative $ from devices used and facility fees with each approach

  2. Radiation Exposure [ Time Frame: 2 years ]
    Total Dose, Fluoroscopy Time, Dose Area Product, Effective dose per fluoroscopy machine readings

  3. Procedure Duration [ Time Frame: 2 years ]
    in minutes

  4. Latency to diagnosis [ Time Frame: 2 years ]
    Duration in days from initial procedure to diagnosis of benign or malignant stricture

  5. Adverse Events [ Time Frame: 2 weeks ]
    (Pancreatitis, Bleeding, Infection, Perforation, Death to be assessed one day, one week post-procedure



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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211169


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

Locations
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United States, California
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Subhas Banerjee, MD         
Principal Investigator: Subhas Banerjee, MD         
Sponsors and Collaborators
Stanford University
University of Rochester
The University of Texas Health Science Center, Houston

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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
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Cholangiocarcinoma
Constriction, Pathologic
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pathological Conditions, Anatomical