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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
Stanford University Medical Center
Stanford, California, United States
RECRUITINGAnastomotic biliary stricture resolution
Fluoroscopic (on ERCP image) resolution of stricture at the time of final study ERCP when all stents are removed
Time frame: Immediately following final ERCP with stent removal
Fluoroscopy Parameters
Fluoroscopy Time per fluoroscopy machine output
Time frame: 1 day
Adverse Events
Pancreatitis, bleeding, infection, perforation to be assessed one day and one week post-procedure
Time frame: 1 week
Sustained resolution of anastomotic stricture for 6 months
No evidence of recurrent stricture based on clinical status and laboratory studies
Time frame: 6 months after final study ERCP with stent removal
Sustained resolution of anastomotic stricture for 12 months
No evidence of recurrent stricture based on clinical status and laboratory studies
Time frame: 12 months after final study ERCP with stent removal
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