Back to results

cSEMS vs. NEPS in Stricture of Biliary Anastomosis After Liver Transplantation

Primary Purpose

Stenosis of the Bilio-biliary Anastomosis After Orthotopic Liver Transplantation

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Non-expandable plastic stent (plastic endoprosthesis)

Covered self-expandable metal stent (cSEMS)

About this trial

This is an interventional treatment trial for Stenosis of the Bilio-biliary Anastomosis After Orthotopic Liver Transplantation focused on measuring cSEMS, NEPS, ERCP, biliary stricture, biliary stenosis, liver transplantation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

post-OLT stenosis of the bilio-biliary anastomotic

Exclusion Criteria:

non-anastomotic stricture
stent implatation technically not feasible

Sites / Locations

University of Helsinki
Klinik für Gastroenterologie und Hepatologie, Medizinische Hochschule Essen
Department of Internal Medicine I
University of Milano

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

study group NEPS

group cSEMS

Arm Description

implantation of multiple non-expandable plastic stents

implantation of a self-expandable metal stent (cSEMS)

Outcomes

Primary Outcome Measures

Number of interventions (ERCP) to attain resolution of stenosis

Number of interventions (ERC) in study group cSEMS is compared to number of interventions (ERC) in study group NEPS

Secondary Outcome Measures

Occurence and severity of complications related to the endoscopic procedures

Full Information

NCT ID

NCT01393067

First Posted

July 12, 2011

Last Updated

August 27, 2016

Sponsor

Johann Wolfgang Goethe University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01393067

Brief Title

cSEMS vs. NEPS in Stricture of Biliary Anastomosis After Liver Transplantation

Official Title

Comparison of Use of Covered, Self-expandable Metal Stents (cSEMS) and Non-expandable Plastic Stents (NEPS) in Temporary Endoscopic Treatment of Stenosis of the Bilio-biliary Anastomosis After Liver Transplantation

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Johann Wolfgang Goethe University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Stenosis at the bilio-biliary anastomosis occurs in up to 30% of patients after orthotopic liver transplantation. This study compares endoscopic treatment with implantation of multiple plastic endoprostheses vs. use of a removable, covered self-expandable metal stent (cSEMS).

Detailed Description

This is a multi-center randomised trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stenosis of the Bilio-biliary Anastomosis After Orthotopic Liver Transplantation

Keywords

cSEMS, NEPS, ERCP, biliary stricture, biliary stenosis, liver transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

study group NEPS

Arm Type

Active Comparator

Arm Description

implantation of multiple non-expandable plastic stents

Arm Title

group cSEMS

Arm Type

Active Comparator

Arm Description

implantation of a self-expandable metal stent (cSEMS)

Intervention Type

Device

Intervention Name(s)

Non-expandable plastic stent (plastic endoprosthesis)

Other Intervention Name(s)

OptiMed, Boston Scientifiv, MTW

Intervention Description

plastic stent (plastic endoprosthesis)

Intervention Type

Device

Intervention Name(s)

Covered self-expandable metal stent (cSEMS)

Other Intervention Name(s)

Niti-S biliary stent, fully covered

Intervention Description

Removable, covered self-expandable metal stent (cSEMS)

Primary Outcome Measure Information:

Title

Number of interventions (ERCP) to attain resolution of stenosis

Description

Number of interventions (ERC) in study group cSEMS is compared to number of interventions (ERC) in study group NEPS

Time Frame

up to one year

Secondary Outcome Measure Information:

Title

Occurence and severity of complications related to the endoscopic procedures

Time Frame

up to 2 months after ERCP

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: post-OLT stenosis of the bilio-biliary anastomotic Exclusion Criteria: non-anastomotic stricture stent implatation technically not feasible

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jörg Albert, MD

Organizational Affiliation

Johann Wolfgang Goethe University Hospital and Clinics Department of Internal Medicine I

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Helsinki

City

Helsinki

ZIP/Postal Code

340

Country

Finland

Facility Name

Klinik für Gastroenterologie und Hepatologie, Medizinische Hochschule Essen

City

Essen

ZIP/Postal Code

45122

Country

Germany

Facility Name

Department of Internal Medicine I

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

University of Milano

City

Milano

Country

Italy

12. IPD Sharing Statement

Citations:

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

background

PubMed Identifier

19693751

Citation

Wang AY, Ellen K, Berg CL, Schmitt TM, Kahaleh M. Fully covered self-expandable metallic stents in the management of complex biliary leaks: preliminary data - a case series. Endoscopy. 2009 Sep;41(9):781-6. doi: 10.1055/s-0029-1215050. Epub 2009 Aug 19.

Results Reference

background

PubMed Identifier

21618151

Citation

Phillips MS, Bonatti H, Sauer BG, Smith L, Javaid M, Kahaleh M, Schmitt T. Elevated stricture rate following the use of fully covered self-expandable metal biliary stents for biliary leaks following liver transplantation. Endoscopy. 2011 Jun;43(6):512-7. doi: 10.1055/s-0030-1256389. Epub 2011 May 26.

Results Reference

background

PubMed Identifier

28302527

Citation

Tal AO, Finkelmeier F, Filmann N, Kylanpaa L, Udd M, Parzanese I, Cantu P, Dechene A, Penndorf V, Schnitzbauer A, Friedrich-Rust M, Zeuzem S, Albert JG. Multiple plastic stents versus covered metal stent for treatment of anastomotic biliary strictures after liver transplantation: a prospective, randomized, multicenter trial. Gastrointest Endosc. 2017 Dec;86(6):1038-1045. doi: 10.1016/j.gie.2017.03.009. Epub 2017 Mar 14.

Results Reference

derived

Learn more about this trial

cSEMS vs. NEPS in Stricture of Biliary Anastomosis After Liver Transplantation

We'll reach out to this number within 24 hrs