Clinical trial NCT01148199: Self-expandable Metallic Stent Versus Multiple Plastic Stents in Post Orthotopic Liver Transplantation Biliary Stenosis
Official title: Self-expandable Metalic Stent Versus Multiple Plastic Stents in Post OLT Biliary Stenosis: Prospective, Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Biliary Anastomotic Stenosis
Biliary Stricture
Keywords: biliary anastomotic stricture
orthotopic liver transplantation
ERCP
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* post-OLT biliary anastomotic stenosis (at least 1 month post-operative)
* jaundice, cholestasis and/or biliary tree dilation on US

Exclusion Criteria:

* biliary fistulae
* non-anastomotic stricture
* combine anastomotic and non-anastomotic stricture

Primary outcomes:
measure: Post OLT biliary stricture resolution after stent removal
timeFrame: Up to 1 year
Secondary outcomes:
measure: Sustained improvement after endoscopic treatment
timeFrame: 1 year after biliary stenosis resolution
measure: Occurence and severity of complications related to the endoscopic procedures
timeFrame: Up to 1 month
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
state: SP
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: FERNANDA P MARTINS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Israelita Albert Einstein
name: ANGELO P FERRARI, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.