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Biliary complications are one of the most common problems after orthotopic liver transplantation (OLT),occurring in up to 24% of patients.
Anastomotic strictures have been endoscopically managed with plastic stents placement. Recently, partially and fully covered metal stents have been alternatively used to treat refractory benign biliary stenosis. The investigators purpose is to compare efficacy and safety of metallic stents versus multiple plastic stents in the endoscopic management of post transplant biliary complications.
Patients with biliary stricture after OLT will be randomly assigned following simple randomization to temporary placement of fully covered self-expandable metal stent (SEMS) or multiple plastic stents placement were randomized according to a computer generated randomization sequence and allocated in a 1:1 ratio to one of two treatment groups.
Final success will be defined as clinical resolution of the stricture without the need to repeat endoscopic, percutaneous or surgical treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiple plastic stents | Active Comparator | Multiple plastic stents placement after sphincterotomy and stricutre dilation. ERCP repeated every 3 - 4 months during 1-year |
|
| Self-expandable metalic stent | Experimental | Self-expandable metalic stent after sphincterotomy. Stent removal scheduled for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-expandable metalic stent | Device | Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post OLT biliary stricture resolution after stent removal | Post OLT biliary stricture resolution will be evaluated during endoscopic stents removal up to 1 year after initial stents placement. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained improvement after endoscopic treatment | Stricture resolution persistent after 1 year | 1 year after biliary stenosis resolution |
| Occurence and severity of complications related to the endoscopic procedures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| FERNANDA P MARTINS, MD | Hospital Israelita Albert Einstein | Principal Investigator |
| ANGELO P FERRARI, MD | Hospital Israelita Albert Einstein | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Israelita Albert Einstein | São Paulo | São Paulo | 05652900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19523620 | Result | Mahajan A, Ho H, Sauer B, Phillips MS, Shami VM, Ellen K, Rehan M, Schmitt TM, Kahaleh M. Temporary placement of fully covered self-expandable metal stents in benign biliary strictures: midterm evaluation (with video). Gastrointest Endosc. 2009 Aug;70(2):303-9. doi: 10.1016/j.gie.2008.11.029. Epub 2009 Jun 11. | |
| 18294506 | Result |
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|
| Multiple plastic stents | Device | Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis. |
|
|
Occurence and severity of complications after therapeutic ERCP will be evaluated and recorded up to 1 month after endoscopic procedures.
| Up to 1 month |
| Kahaleh M, Behm B, Clarke BW, Brock A, Shami VM, De La Rue SA, Sundaram V, Tokar J, Adams RB, Yeaton P. Temporary placement of covered self-expandable metal stents in benign biliary strictures: a new paradigm? (with video). Gastrointest Endosc. 2008 Mar;67(3):446-54. doi: 10.1016/j.gie.2007.06.057. |
| 19877248 | Result | Traina M, Tarantino I, Barresi L, Volpes R, Gruttadauria S, Petridis I, Gridelli B. Efficacy and safety of fully covered self-expandable metallic stents in biliary complications after liver transplantation: a preliminary study. Liver Transpl. 2009 Nov;15(11):1493-8. doi: 10.1002/lt.21886. |