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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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Stanford University

Status

Unknown

Conditions

Anastomotic Stenosis
Biliary Stricture

Treatments

Procedure: Protocol for increasing number of stents across the anastomosis

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Sequential stent addition
Experimental group
Description:
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.
Treatment:
Procedure: Protocol for increasing number of stents across the anastomosis
Incremental Dilation & Stent Exchange
Active Comparator group
Description:
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.
Treatment:
Procedure: Protocol for increasing number of stents across the anastomosis

Trial contacts and locations

1

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Central trial contact

Subhas Banerjee, MD

Data sourced from clinicaltrials.gov

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