Non-expandable plastic stent (plastic endoprosthesis)
Deviceplastic stent (plastic endoprosthesis)
Other names: OptiMed, Boston Scientifiv, MTW
Completed
NCT Number: NCT01393067
cSEMS vs. NEPS in Stricture of Biliary Anastomosis After Liver Transplantation
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).
Completed
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Notify MeKey information
Age range
18 year–90 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
University of Helsinki, Helsinki, Finland
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About this study
This is a multi-center randomised trial.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- post-OLT stenosis of the bilio-biliary anastomotic
Exclusion criteria
- non-anastomotic stricture
- stent implatation technically not feasible
Treatment and study plan
Covered self-expandable metal stent (cSEMS)
DeviceRemovable, covered self-expandable metal stent (cSEMS)
Other names: Niti-S biliary stent, fully covered
Primary outcomes
-
Number of interventions (ERCP) to attain resolution of stenosis
Time frame: up to one year
Number of interventions (ERC) in study group cSEMS is compared to number of interventions (ERC) in study group NEPS
Secondary outcomes
-
Occurence and severity of complications related to the endoscopic procedures
Time frame: up to 2 months after ERCP
Sponsors and collaborators
Lead sponsor
Johann Wolfgang Goethe University Hospital
Other
Registry information
Official study 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
Important dates
- Study start
- 2011
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Jul 13, 2011
- Registry last updated
- Aug 30, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.