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

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

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.

Study Overview

• Status: Completed
• Conditions: Biliary Stricture; Biliary Anastomotic Stenosis
• Intervention / Treatment: Device: Multiple plastic stents; Device: Self-expandable metalic stent

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 05652900
      • Hospital Israelita Albert Einstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Multiple plastic stents; Multiple plastic stents placement after sphincterotomy and stricutre dilation. ERCP repeated every 3 - 4 months during 1-year	Device: Multiple plastic stents; Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.; Other Names: Boston Scientific; Wilson Cook; Olympus
EXPERIMENTAL: Self-expandable metalic stent; Self-expandable metalic stent after sphincterotomy. Stent removal scheduled for 6 months	Device: Self-expandable metalic stent; Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.; Other Names: Wallflex, Boston Scientific

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Occurence and severity of complications after therapeutic ERCP will be evaluated and recorded up to 1 month after endoscopic procedures.	Up to 1 month

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Investigators: Principal Investigator: FERNANDA P MARTINS, MD, Hospital Israelita Albert Einstein; Study Chair: ANGELO P FERRARI, MD, Hospital Israelita Albert Einstein

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (ACTUAL): February 1, 2015
• Study Completion (ACTUAL): February 1, 2016

Study Registration Dates

• First Submitted: June 21, 2010
• First Submitted That Met QC Criteria: June 21, 2010
• First Posted (ESTIMATE): June 22, 2010

Study Record Updates

• Last Update Posted (ACTUAL): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 22, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: ERCP; orthotopic liver transplantation; biliary anastomotic stricture
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: 1219-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED