Stenosis of the Bilio-biliary Anastomosis After Orthotopic Liver TransplantationNCT01393067
cSEMS vs. NEPS in Stricture of Biliary Anastomosis After Liver Transplantation
A study testing Non-expandable plastic stent (plastic endoprosthesis) and Covered self-expandable metal stent (cSEMS) in people with Stenosis of the Bilio-biliary Anastomosis After Orthotopic Liver Transplantation, run by Johann Wolfgang Goethe University Hospital at 4 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stenosis of the Bilio-biliary Anastomosis After Orthotopic Liver Transplantation
- What is being tested?
- Non-expandable plastic stent (plastic endoprosthesis) and Covered self-expandable metal stent (cSEMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Mar 2011to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- post-OLT stenosis of the bilio-biliary anastomotic
Who cannot join
- non-anastomotic stricture
- stent implatation technically not feasible
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Germany2 sites
Klinik für Gastroenterologie und Hepatologie, Medizinische Hochschule Essen
Essen, 45122
Department of Internal Medicine I
Frankfurt, 60590
About this study
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
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).
Read the detailed description
This is a multi-center randomised trial.
- Being tested
- Non-expandable plastic stent (plastic endoprosthesis), Covered self-expandable metal stent (cSEMS)
- Keywords
- cSEMS, NEPS, ERCP, biliary stricture, biliary stenosis, liver transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-expandable plastic stent (plastic endoprosthesis)Device
Also called OptiMed, Boston Scientifiv, MTW
plastic stent (plastic endoprosthesis)
Covered self-expandable metal stent (cSEMS)Device
Also called Niti-S biliary stent, fully covered
Removable, covered self-expandable metal stent (cSEMS)
| Study group | Role | What they receive |
|---|---|---|
| study group NEPS | Active comparator | implantation of multiple non-expandable plastic stents Receives: Device: Non-expandable plastic stent (plastic endoprosthesis) |
| group cSEMS | Active comparator | implantation of a self-expandable metal stent (cSEMS) Receives: Device: Covered self-expandable metal stent (cSEMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to one year
Secondary outcomes (1)
Occurence and severity of complications related to the endoscopic procedures
Measured: up to 2 months after ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stenosis of the Bilio-biliary Anastomosis After Orthotopic Liver TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorg Albert, Johann Wolfgang Goethe University Hospital
- Investigators
- Jörg Albert, MD, Principal investigator, Johann Wolfgang Goethe University Hospital and Clinics Department of Internal Medicine I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393067
- Sponsor's protocol ID
- 148/10
- Status last verified
- Aug 2016
- First submitted
- 12 Jul 2011
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18294506Wang 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.
PubMed 19693751Phillips 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.
PubMed 21618151Tal 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.
PubMed 28302527
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01393067
- Acronym / sponsor ID
- 148/10
- Keywords
- cSEMS, NEPS, ERCP, biliary stricture, biliary stenosis, liver transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group NEPS | Active comparator | Device: Non-expandable plastic stent (plastic endoprosthesis)implantation of multiple non-expandable plastic stents |
| group cSEMS | Active comparator | Device: Covered self-expandable metal stent (cSEMS)implantation of a self-expandable metal stent (cSEMS) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- post-OLT stenosis of the bilio-biliary anastomotic
Key exclusion criteria (2 listed)
- non-anastomotic stricture
- stent implatation technically not feasible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-expandable plastic stent (plastic endoprosthesis)Also: OptiMed, Boston Scientifiv, MTWplastic stent (plastic endoprosthesis) | Device | study group NEPS |
| Covered self-expandable metal stent (cSEMS)Also: Niti-S biliary stent, fully coveredRemovable, covered self-expandable metal stent (cSEMS) | Device | group cSEMS |
Primary outcome
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
1 secondary outcome
Occurence and severity of complications related to the endoscopic procedures
Time frame: up to 2 months after ERCP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Background: PubMed 18294506Kahaleh 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.
- Background: PubMed 19693751Wang 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.
- Background: PubMed 21618151Phillips 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.
- Derived from this study: PubMed 28302527Tal 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jörg Albert, MD principal investigator
Johann Wolfgang Goethe University Hospital and Clinics Department of Internal Medicine I
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-expandable plastic stent (plastic endoprosthesis) and Covered self-expandable metal stent (cSEMS) in people with Stenosis of the Bilio-biliary Anastomosis After Orthotopic Liver Transplantation, run by Johann Wolfgang Goethe University Hospital at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Finland, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of interventions (ERCP) to attain resolution of stenosis (time frame: up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01393067, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2016.