Self-expandable Metallic Stent Versus Multiple Plastic Stents in Post Orthotopic Liver Transplantation Biliary Stenosis
Primary Purpose
Biliary Anastomotic Stenosis, Biliary Stricture
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Self-expandable metalic stent
Multiple plastic stents
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Anastomotic Stenosis focused on measuring biliary anastomotic stricture, orthotopic liver transplantation, ERCP
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
Sites / Locations
- Hospital Israelita Albert Einstein
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Multiple plastic stents
Self-expandable metalic stent
Arm Description
Multiple plastic stents placement after sphincterotomy and stricutre dilation. ERCP repeated every 3 - 4 months during 1-year
Self-expandable metalic stent after sphincterotomy. Stent removal scheduled for 6 months
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Sustained improvement after endoscopic treatment
Stricture resolution persistent after 1 year
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.
Full Information
NCT ID
NCT01148199
First Posted
June 21, 2010
Last Updated
June 22, 2018
Sponsor
Hospital Israelita Albert Einstein
1. Study Identification
Unique Protocol Identification Number
NCT01148199
Brief Title
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
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Israelita Albert Einstein
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Anastomotic Stenosis, Biliary Stricture
Keywords
biliary anastomotic stricture, orthotopic liver transplantation, ERCP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multiple plastic stents
Arm Type
Active Comparator
Arm Description
Multiple plastic stents placement after sphincterotomy and stricutre dilation. ERCP repeated every 3 - 4 months during 1-year
Arm Title
Self-expandable metalic stent
Arm Type
Experimental
Arm Description
Self-expandable metalic stent after sphincterotomy. Stent removal scheduled for 6 months
Intervention Type
Device
Intervention Name(s)
Self-expandable metalic stent
Other Intervention Name(s)
Wallflex, Boston Scientific
Intervention Description
Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.
Intervention Type
Device
Intervention Name(s)
Multiple plastic stents
Other Intervention Name(s)
Boston Scientific, Wilson Cook, Olympus
Intervention Description
Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.
Primary Outcome Measure Information:
Title
Post OLT biliary stricture resolution after stent removal
Description
Post OLT biliary stricture resolution will be evaluated during endoscopic stents removal up to 1 year after initial stents placement.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Sustained improvement after endoscopic treatment
Description
Stricture resolution persistent after 1 year
Time Frame
1 year after biliary stenosis resolution
Title
Occurence and severity of complications related to the endoscopic procedures
Description
Occurence and severity of complications after therapeutic ERCP will be evaluated and recorded up to 1 month after endoscopic procedures.
Time Frame
Up to 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FERNANDA P MARTINS, MD
Organizational Affiliation
Hospital Israelita Albert Einstein
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ANGELO P FERRARI, MD
Organizational Affiliation
Hospital Israelita Albert Einstein
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Israelita Albert Einstein
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05652900
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19523620
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.
Results Reference
result
PubMed Identifier
18294506
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.
Results Reference
result
PubMed Identifier
19877248
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.
Results Reference
result
Learn more about this trial
Self-expandable Metallic Stent Versus Multiple Plastic Stents in Post Orthotopic Liver Transplantation Biliary Stenosis
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