Self-expandable Metallic Stent Versus Multiple Plastic Stents in Post Orthotopic Liver Transplantation Biliary Stenosis

Biliary Stricture Clinical Trial

Official title:

Self-expandable Metalic Stent Versus Multiple Plastic Stents in Post OLT Biliary Stenosis: Prospective, Randomized, Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01148199
• Other study ID #: 1219-10
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 2009
• Est. completion date: February 2016

Study information

• Verified date: June 2018
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Biliary Anastomotic Stenosis
• Biliary Stricture
• Constriction, Pathologic

Intervention

Device:
• Self-expandable metalic stent
Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.
• Multiple plastic stents
Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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;6 — View 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): — View 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( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Sustained improvement after endoscopic treatment	Stricture resolution persistent after 1 year	1 year after biliary stenosis resolution
Secondary	Occurence and severity of complications related to the endoscopic procedures	Occurence and severity of complications after therapeutic ERCP will be evaluated and recorded up to 1 month after endoscopic procedures.	Up to 1 month