NCT01148199

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

5.5 years

First QC Date

June 21, 2010

Last Update Submit

June 22, 2018

Conditions

Biliary Anastomotic StenosisBiliary Stricture

Keywords

biliary anastomotic strictureorthotopic liver transplantationERCP

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Sustained improvement after endoscopic treatment

    1 year after biliary stenosis resolution

  • Occurence and severity of complications related to the endoscopic procedures

    Up to 1 month

Study Arms (2)

Multiple plastic stents

ACTIVE COMPARATOR

Multiple plastic stents placement after sphincterotomy and stricutre dilation. ERCP repeated every 3 - 4 months during 1-year

Device: Multiple plastic stents

Self-expandable metalic stent

EXPERIMENTAL

Self-expandable metalic stent after sphincterotomy. Stent removal scheduled for 6 months

Device: Self-expandable metalic stent

Interventions

Self-expandable metalic stentDEVICE

Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.

Also known as: Wallflex, Boston Scientific
Self-expandable metalic stent
Multiple plastic stentsDEVICE

Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.

Also known as: Boston Scientific, Wilson Cook, Olympus
Multiple plastic stents

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05652900, Brazil

Location

Related Publications (3)

  • 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.

    PMID: 19523620RESULT

  • 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.

    PMID: 18294506RESULT

  • 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.

    PMID: 19877248RESULT

Study Officials

  • FERNANDA P MARTINS, MD

    Hospital Israelita Albert Einstein

    PRINCIPAL INVESTIGATOR

  • ANGELO P FERRARI, MD

    Hospital Israelita Albert Einstein

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending phisician

Study Record Dates

First Submitted

June 21, 2010

First Posted

June 22, 2010

Study Start

August 1, 2009

Primary Completion

February 1, 2015

Study Completion

February 1, 2016

Last Updated

June 26, 2018

Record last verified: 2018-06

Locations

BR(1)