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| Name | Class |
|---|---|
| University of Rochester | OTHER |
| University of Barcelona | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequential stent addition | Experimental | 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. |
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| Incremental Dilation & Stent Exchange | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protocol for increasing number of stents across the anastomosis | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Anastomotic biliary stricture resolution | Fluoroscopic (on ERCP image) resolution of stricture at the time of final study ERCP when all stents are removed | Immediately following final ERCP with stent removal |
| Measure | Description | Time Frame |
|---|---|---|
| Fluoroscopy Parameters | Fluoroscopy Time per fluoroscopy machine output | 1 day |
| Adverse Events | Pancreatitis, bleeding, infection, perforation to be assessed one day and one week post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Subhas Banerjee, MD | Contact | 650-723-2623 | sbanerje@stanford.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Recruiting | Stanford | California | 94305 | United States |
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Randomized prospective study
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| 1 week |
| Sustained resolution of anastomotic stricture for 6 months | No evidence of recurrent stricture based on clinical status and laboratory studies | 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 | 12 months after final study ERCP with stent removal |
| ID | Term |
|---|---|
| D002985 | Clinical Protocols |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D016020 | Epidemiologic Study Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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