Biliary Anastomotic StenosisPhase 2/3NCT01148199
Self-expandable Metallic Stent Versus Multiple Plastic Stents in Post Orthotopic Liver Transplantation Biliary Stenosis
A Phase 2/3 study testing Self-expandable metalic stent and Multiple plastic stents in people with Biliary Anastomotic Stenosis and Biliary Stricture, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Anastomotic Stenosis, Biliary Stricture
- What is being tested?
- Self-expandable metalic stent and Multiple plastic stents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2009to Feb 2016
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- post-OLT biliary anastomotic stenosis (at least 1 month post-operative)
- jaundice, cholestasis and/or biliary tree dilation on US
Who cannot join
- biliary fistulae
- non-anastomotic stricture
- combine anastomotic and non-anastomotic stricture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-expandable Metalic Stent Versus Multiple Plastic Stents in Post OLT Biliary Stenosis: Prospective, Randomized, Controlled Trial.
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.
Read the 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.
- Conditions
- Biliary Anastomotic Stenosis, Biliary Stricture
- Being tested
- Self-expandable metalic stent, Multiple plastic stents
- Keywords
- biliary anastomotic stricture, orthotopic liver transplantation, ERCP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-expandable metalic stentDevice
Also called Wallflex, Boston Scientific
Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.
Multiple plastic stentsDevice
Also called Boston Scientific, Wilson Cook, Olympus
Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.
| Study group | Role | What they receive |
|---|---|---|
| Multiple plastic stents | Active comparator | Multiple plastic stents placement after sphincterotomy and stricutre dilation. ERCP repeated every 3 - 4 months during 1-year Receives: Device: Multiple plastic stents |
| Self-expandable metalic stent | Experimental | Self-expandable metalic stent after sphincterotomy. Stent removal scheduled for 6 months Receives: Device: Self-expandable metalic stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year
Secondary outcomes (2)
Sustained improvement after endoscopic treatment
Stricture resolution persistent after 1 year
Measured: 1 year after biliary stenosis resolution
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.
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startAug 2009
- Primary completionFeb 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Biliary Anastomotic StenosisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FERNANDA PRATA MARTINS, Hospital Israelita Albert Einstein
- Investigators
- FERNANDA P MARTINS, MD, Principal investigator, Hospital Israelita Albert EinsteinANGELO P FERRARI, MD, Study chair, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148199
- Sponsor's protocol ID
- 1219-10
- Status last verified
- Jun 2018
- First submitted
- 21 Jun 2010
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19523620Kahaleh 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 18294506Traina 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.
PubMed 19877248
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-expandable Metalic Stent Versus Multiple Plastic Stents in Post OLT Biliary Stenosis: Prospective, Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT01148199
- Acronym / sponsor ID
- 1219-10
- Conditions
- Biliary Anastomotic Stenosis, Biliary Stricture
- Keywords
- biliary anastomotic stricture, orthotopic liver transplantation, ERCP
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 22 Jun 2010 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple plastic stents | Active comparator | Device: Multiple plastic stentsMultiple plastic stents placement after sphincterotomy and stricutre dilation. ERCP repeated every 3 - 4 months during 1-year |
| Self-expandable metalic stent | Experimental | Device: Self-expandable metalic stentSelf-expandable metalic stent after sphincterotomy. Stent removal scheduled for 6 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- post-OLT biliary anastomotic stenosis (at least 1 month post-operative)
- jaundice, cholestasis and/or biliary tree dilation on US
Key exclusion criteria (3 listed)
- biliary fistulae
- non-anastomotic stricture
- combine anastomotic and non-anastomotic stricture
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 |
|---|---|---|
| Self-expandable metalic stentAlso: Wallflex, Boston ScientificComparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis. | Device | Self-expandable metalic stent |
| Multiple plastic stentsAlso: Boston Scientific, Wilson Cook, OlympusComparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis. | Device | Multiple plastic stents |
Primary outcome
Post OLT biliary stricture resolution after stent removal
Time frame: Up to 1 year
Post OLT biliary stricture resolution will be evaluated during endoscopic stents removal up to 1 year after initial stents placement.
2 secondary outcomes
Sustained improvement after endoscopic treatment
Time frame: 1 year after biliary stenosis resolution
Occurence and severity of complications related to the endoscopic procedures
Time frame: Up to 1 month
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 26 Jun 2018.
- Results publication: PubMed 19523620Mahajan 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 publication: 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.
- Results publication: PubMed 19877248Traina 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.
- Individual participant dataSharing planned: Undecided
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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.
FERNANDA P MARTINS, MD principal investigator
Hospital Israelita Albert Einstein
ANGELO P FERRARI, MD study chair
Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Self-expandable metalic stent and Multiple plastic stents in people with Biliary Anastomotic Stenosis and Biliary Stricture, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
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 2 inclusion and 3 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 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Post OLT biliary stricture resolution after stent removal (time frame: Up to 1 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 NCT01148199, which also lists 3 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 26 Jun 2018.