Biliary StrictureNCT02105181
Fully Covered Self-expandable Metal Stents (FCMS) in Benign Biliary Strictures
A study testing Placement of a FCMS in the biliary tract of the patients in people with Biliary Stricture, run by Société Française d'Endoscopie Digestive at 1 site in France.
Trial summary
Endoscopic treatment of benign biliary strictures can be challenging. Balloon dilation and/or plastic stent placement are currently the most popular techniques. Partially covered self-expandable metallic stents have also shown to be effective but can be difficult to remove. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Biliary Stricture
- What is being tested?
- Placement of a FCMS in the biliary tract of the patients
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2007to Mar 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- a history of liver transplantation, chronic pancreatitis or biliary surgery
- impairment of liver function tests such as elevated liver enzymes and/or cholestasis
- a biliary stricture associated with ductal dilation detected by US, CT or MRI, with a minimum distance of 2cm between the upper stricture's edge and the lower limit of the main biliary confluence or liver hilum .
Who cannot join
- an uncertainty about the benign nature of the stricture
- an intra-hepatic cholangitis and/ or a stricture extending beyond the hilum
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Temporary Placement of Fully Covered Self-expandable Metal Stents in Benign Biliary Strictures
Endoscopic treatment of benign biliary strictures can be challenging. Balloon dilation and/or plastic stent placement are currently the most popular techniques. Partially covered self-expandable metallic stents have also shown to be effective but can be difficult to remove. A novel fully covered metallic stent has recently been developed.
The aim of this study was to prospectively evaluate the placement of fully covered self-expandable metallic stents (FCSEMS) in this setting.
Read the detailed description
After inclusion, an endoscopic procedure (ERCP) was performed in all patients in order to place a FCMS across the benign biliary stricture. The FCMS was left in place for 6 months and then extracted during a second ERCP procedure. An opacification was performed to assess the efficacy of stenting. Patients were followed up during one year after FCMS extraction.
- Conditions
- Biliary Stricture
- Being tested
- Placement of a FCMS in the biliary tract of the patients
- Keywords
- benign biliary stricture, anastomotic biliary stricture after liver transplantation, chronic pancreatitis, biliary surgical procedure, fully covered metal stent
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of a FCMS in the biliary tract of the patientsDevice
During an ERCP procedure, a fully covered biliary metal stent (FCMS) is placed across a benign biliary stricture
| Study group | Role | What they receive |
|---|---|---|
| Fully covered metal stent (FCMS) | Other | There is one arm in the study : the intervention consists on placing a device which is a fully covered metal stent in the biliary tract of all patients Receives: Device: Placement of a FCMS in the biliary tract of the patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial success rate of temporary FCMS placement
Absence of biliary stricture or as an attenuated stricture on cholangiogram after removal of FCMS
Measured: 6 months
Secondary outcomes (2)
Final success
Absence of biliary stricture or the presence of an attenuated stricture and normal liver function tests at the end of follow up.
Measured: 18 months
Stricture recurrence
Both clinically and ERCP-documented recurrence of stricture after an initial success.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startMar 2007
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary StrictureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société Française d'Endoscopie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaput Ulriikka, Société Française d'Endoscopie Digestive
- Investigators
- Frederic Prat, MD, PhD, Principal investigator, Société Française d'Endoscopie Digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105181
- Sponsor's protocol ID
- 2006-A00197-44
- Status last verified
- Apr 2014
- First submitted
- 2 Apr 2014
- Last updated
- 8 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporary Placement of Fully Covered Self-expandable Metal Stents in Benign Biliary Strictures
- ClinicalTrials.gov ID
- NCT02105181
- Acronym / sponsor ID
- 2006-A00197-44
- Conditions
- Biliary Stricture
- Keywords
- benign biliary stricture, anastomotic biliary stricture after liver transplantation, chronic pancreatitis, biliary surgical procedure, fully covered metal stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Société Française d'Endoscopie DigestiveUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 7 Apr 2014 (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.
Endoscopic treatment of benign biliary strictures can be challenging. Balloon dilation and/or plastic stent placement are currently the most popular techniques. Partially covered self-expandable metallic stents have also shown to be effective but can be difficult to remove. A novel fully covered metallic stent has recently been developed.
The aim of this study was to prospectively evaluate the placement of fully covered self-expandable metallic stents (FCSEMS) in this setting.
Detailed description
After inclusion, an endoscopic procedure (ERCP) was performed in all patients in order to place a FCMS across the benign biliary stricture. The FCMS was left in place for 6 months and then extracted during a second ERCP procedure. An opacification was performed to assess the efficacy of stenting. Patients were followed up during one year after FCMS extraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fully covered metal stent (FCMS) | Other | Device: Placement of a FCMS in the biliary tract of the patientsThere is one arm in the study : the intervention consists on placing a device which is a fully covered metal stent in the biliary tract of all patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- a history of liver transplantation, chronic pancreatitis or biliary surgery
- impairment of liver function tests such as elevated liver enzymes and/or cholestasis
- a biliary stricture associated with ductal dilation detected by US, CT or MRI, with a minimum distance of 2cm between the upper stricture's edge and the lower limit of the main biliary confluence or liver hilum .
Key exclusion criteria (2 listed)
- an uncertainty about the benign nature of the stricture
- an intra-hepatic cholangitis and/ or a stricture extending beyond the hilum
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 |
|---|---|---|
| Placement of a FCMS in the biliary tract of the patientsDuring an ERCP procedure, a fully covered biliary metal stent (FCMS) is placed across a benign biliary stricture | Device | Fully covered metal stent (FCMS) |
Primary outcome
Initial success rate of temporary FCMS placement
Time frame: 6 months
Absence of biliary stricture or as an attenuated stricture on cholangiogram after removal of FCMS
2 secondary outcomes
Final success
Time frame: 18 months
Stricture recurrence
Time frame: 18 months
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 8 Apr 2014.
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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.
Frederic Prat, MD, PhD principal investigator
Société Française d'Endoscopie Digestive
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of a FCMS in the biliary tract of the patients in people with Biliary Stricture, run by Société Française d'Endoscopie Digestive at 1 site in France.
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 3 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 8 Apr 2014. 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 France. 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?
Initial success rate of temporary FCMS placement (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2014.