Anastomotic Stenosis, Biliary Stricture
Conditions
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.
Interventions
PROCEDUREProtocol 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.
Sponsors
University of Rochester
University of Barcelona
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized prospective study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anastomotic biliary stricture resolution | 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
| Measure | Time frame | Description |
|---|---|---|
| Fluoroscopy Parameters | 1 day | Fluoroscopy Time per fluoroscopy machine output |
| Adverse Events | 1 week | Pancreatitis, bleeding, infection, perforation to be assessed one day and one week post-procedure |
| Sustained resolution of anastomotic stricture for 6 months | 6 months after final study ERCP with stent removal | No evidence of recurrent stricture based on clinical status and laboratory studies |
| Sustained resolution of anastomotic stricture for 12 months | 12 months after final study ERCP with stent removal | No evidence of recurrent stricture based on clinical status and laboratory studies |
Countries
United States
Contacts
Primary ContactSubhas Banerjee, MD
Outcome results
None listed