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Evaluation of Sequential Stent Addition vs. Incremental Dilation & Stent Exchange for Management of Anastomotic Biliary Strictures After Liver Transplantation

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ClinicalTrials.gov Identifier: NCT03229655
Recruitment Status : Not yet recruiting
First Posted : July 25, 2017
Last Update Posted : July 25, 2017
Sponsor:
Collaborators:
University of Rochester
University of Barcelona
Information provided by (Responsible Party):
Subhas Banerjee, Stanford University

Brief Summary:
Prospective, randomized comparison of the incremental dilation and stent exchange vs. sequential stent addition approaches for management of anastomotic biliary strictures will facilitate optimal management of patients who develop anastomotic biliary strictures after liver transplantation.

Condition or disease Intervention/treatment Phase
Anastomotic Stenosis Biliary Stricture Procedure: Protocol for increasing number of stents across the anastomosis Not Applicable

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: Treatment
Official Title: Evaluation of Sequential Stent Addition vs. Incremental Dilation & Stent Exchange for Management of Anastomotic Biliary Strictures After Liver Transplantation
Estimated Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sequential stent addition
ERCP with sphincterotomy and stent placement is initially performed, then additional stents are placed across the stricture during sequential ERCPs, without stent removal/exchange or stricture dilation.
Procedure: Protocol for increasing number of stents across the anastomosis
Sequential placement of straight plastic biliary stents across the duct-to-duct anastomosis without dilation or stent exchange. Multiple ERCPs will be performed with addition of a single stent at each ERCP until the final ERCP when all stents will be removed.

Active Comparator: Incremental Dilation & Stent Exchange
ERCP with sphincterotomy and stent placement is initially performed, with subsequent ERCPs involving removal of previously placed stents, stricture dilation and balloon sweeps to extract stone debris/sludge.
Procedure: Protocol for increasing number of stents across the anastomosis
Sequential placement of straight plastic biliary stents across the duct-to-duct anastomosis without dilation or stent exchange. Multiple ERCPs will be performed with addition of a single stent at each ERCP until the final ERCP when all stents will be removed.




Primary Outcome Measures :
  1. Anastomotic biliary stricture resolution [ Time Frame: Immediately following final ERCP with stent removal ]
    Fluoroscopic (on ERCP image) resolution of stricture at the time of final study ERCP when all stents are removed


Secondary Outcome Measures :
  1. Fluoroscopy Parameters [ Time Frame: 1 day ]
    Fluoroscopy Time per fluoroscopy machine output

  2. Adverse Events [ Time Frame: 1 week ]
    Pancreatitis, bleeding, infection, perforation to be assessed one day and one week post-procedure

  3. Sustained resolution of anastomotic stricture for 6 months [ Time Frame: 6 months after final study ERCP with stent removal ]
    No evidence of recurrent stricture based on clinical status and laboratory studies

  4. Sustained resolution of anastomotic stricture for 12 months [ Time Frame: 12 months after final study ERCP with stent removal ]
    No evidence of recurrent stricture based on clinical status and laboratory studies



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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. Age 18 and older
  2. Clinical concern for anastomotic biliary stricture following liver transplantation (as determined by the referring transplant hepatologist)
  3. Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

  1. Age <18
  2. Potentially vulnerable subjects including, homeless people, pregnant females, employees and students.
  3. Complex post-surgical anatomy e.g. Choledochojejunostomy, Billroth type II anatomy, Roux-en-Y-gastrojejunostomy
  4. Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
  5. Other biliary process which accounts for patient's abnormal liver function studies/imaging (i.e. significant non-anastomotic biliary stricture).

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): NCT03229655


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

Sponsors and Collaborators
Stanford University
University of Rochester
University of Barcelona

Responsible Party: Subhas Banerjee, Associate Professor of Medicine, Division of Gastroenterology, Stanford University
ClinicalTrials.gov Identifier: NCT03229655     History of Changes
Other Study ID Numbers: 41606
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 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
Cholestasis
Pathological Conditions, Anatomical
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases