Biliary Strictures Post Liver TransplantationNCT01339078
Trial Comparing Kaffes Stent With Plastic Prosthesis in the Treatment of Anastomotic Biliary Strictures Post Orthotopic Liver Transplantation
A study testing Plastic stenting and Kaffes stenting in people with Biliary Strictures Post Liver Transplantation, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Biliary anastomotic strictures (post liver transplantation) occur in 15-20 % of the cases. Biliary stenting using plastic prosthesis during a period of 1 year is the treatment of choice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Strictures Post Liver Transplantation
- What is being tested?
- Plastic stenting and Kaffes stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2011to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients after orthotopic liver transplantation with a choledocho- choledochal anastomosis, presenting with an anastomotic stricture
- diagnosis established by :
- elevated liver tests
- a narrowing of the anastomosis on Magnetic resonance cholangiopancreatography (MRCP): with or without intrahepatic bile duct dilatation
- no acute or chronic rejection
- no Cytomegalovirus (CMV) infection
- no other possible causes of elevated liver tests
- confirmation of the stricture needs to be confirmed during the diagnostic endoscopic retrograde cholangiopancreatography (ERCP) procedure immediately before the therapeutic procedure.
Who cannot join
- non-anastomotic strictures
- absence of informed consent
- Roux-en-Y construction
- Living related liver transplantation patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Comparing Kaffes Stent With Plastic Prosthesis in the Treatment of Anastomotic Biliary Strictures Post Orthotopic Liver Transplantation
Biliary anastomotic strictures (post liver transplantation) occur in 15-20 % of the cases. Biliary stenting using plastic prosthesis during a period of 1 year is the treatment of choice. Problematic in this approach is the regular change, necessary to overcome occlusion of the stent, resulting in cholestasis and/or infection. This change needs to be performed every 3 months or more frequently in patients with symptoms of stent occlusion.
The Kaffes stent (RMS) is a metallic removable stent, especially constructed for the treatment of biliary anastomotic strictures post liver transplantation. The advantage could be that this stent is less prone to occlusion with a lower change frequency (e.g. every 6 months).
No randomized, controlled trial (RCT) or data exist comparing plastic stenting versus Kaffes stenting.
- Being tested
- Plastic stenting, Kaffes stenting
- Keywords
- Biliary strictures, liver transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plastic stentingProcedure or surgery
The patients receive plastic stenting after ortothopic liver transplantation with a choledocho-choledochal anastomosis, presenting with an anastomotic stricture. These patients will receive change of the stent every 3 months, for a total duration of 1 year.
Kaffes stentingProcedure or surgery
The patients receive Kaffes stenting after ortothopic liver transplantation with a choledocho-choledochal anastomosis, presenting with an anastomotic stricture. These patients will receive change of the stent every 6 months, for a total duration of 1 year.
| Study group | Role | What they receive |
|---|---|---|
| Plastic stenting | Active comparator | Patients will be randomized towards plastic stenting. Receives: Procedure: Plastic stenting |
| Kaffes stenting | Experimental | Patients will be randomized towards Kaffes stenting. Receives: Procedure: Kaffes stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of patency of the bile duct between normal and Kaffes stenting.
Comparison of patency of the bile duct 6 months after 1 year of stenting. Patency is defined as the presence of normal liver function test (direct bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transpeptidase (gamma-GT), alkaline phosphatase) and non-dilated bile ducts on Magnetic resonance cholangiopancreatography (MRCP). In the presence of cytomegalovirus (CMV) infection, rejection or other causes of possible disturbed liver function parameters, the MRCP findings rule over the lab tests.
Measured: after 6 months and after 1 year
Secondary outcomes (4)
safety of the Kaffes stent
The safety of the Kaffes stent, compared to the normal stent will be assessed (e.g. change of stents, blood tests, endoscopic retrograde cholangio-pancreatography (ERCP)).
Measured: during a period of 1 year
Duration of hospitalization
Measured: during a period of 1 year
Number of stent changes
Patients included in the plastic stenting arm will receive change of stents every 3 months for a total duration of 1 year.
Patients included in the Kaffes stent arm will receive change of the stent every 6 months for a total duration of 1 year.
In case the patient develops symptoms of stent occlusion (rise of liver tests, fever, septicimiae), the stent will be changed as soon as possible.
Measured: during a period of 1 year
Comparison of costs between normal stenting and Kaffes stenting.
Comparison of costs over a period of 1 year between normal stenting and Kaffes stenting will be evaluated.
Measured: during a period of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Strictures Post Liver TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans Van Vlierberghe, Ph.D., M.D., Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339078
- Sponsor's protocol ID
- 2011/255
- Status last verified
- Dec 2022
- First submitted
- 18 Apr 2011
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Kaffes Stent With Plastic Prosthesis in the Treatment of Anastomotic Biliary Strictures Post Orthotopic Liver Transplantation
- ClinicalTrials.gov ID
- NCT01339078
- Acronym / sponsor ID
- 2011/255
- Keywords
- Biliary strictures, liver transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Sep 2011 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Apr 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.
Biliary anastomotic strictures (post liver transplantation) occur in 15-20 % of the cases. Biliary stenting using plastic prosthesis during a period of 1 year is the treatment of choice. Problematic in this approach is the regular change, necessary to overcome occlusion of the stent, resulting in cholestasis and/or infection. This change needs to be performed every 3 months or more frequently in patients with symptoms of stent occlusion.
The Kaffes stent (RMS) is a metallic removable stent, especially constructed for the treatment of biliary anastomotic strictures post liver transplantation. The advantage could be that this stent is less prone to occlusion with a lower change frequency (e.g. every 6 months).
No randomized, controlled trial (RCT) or data exist comparing plastic stenting versus Kaffes stenting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plastic stenting | Active comparator | Procedure: Plastic stentingPatients will be randomized towards plastic stenting. |
| Kaffes stenting | Experimental | Procedure: Kaffes stentingPatients will be randomized towards Kaffes stenting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients after orthotopic liver transplantation with a choledocho- choledochal anastomosis, presenting with an anastomotic stricture
- diagnosis established by :
Key exclusion criteria (4 listed)
- non-anastomotic strictures
- absence of informed consent
- Roux-en-Y construction
- Living related liver transplantation patients.
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 |
|---|---|---|
| Plastic stentingThe patients receive plastic stenting after ortothopic liver transplantation with a choledocho-choledochal anastomosis, presenting with an anastomotic stricture. These patients will receive change of the stent every 3 months, for a total duration of 1 year. | Procedure or surgery | Plastic stenting |
| Kaffes stentingThe patients receive Kaffes stenting after ortothopic liver transplantation with a choledocho-choledochal anastomosis, presenting with an anastomotic stricture. These patients will receive change of the stent every 6 months, for a total duration of 1 year. | Procedure or surgery | Kaffes stenting |
Primary outcome
Comparison of patency of the bile duct between normal and Kaffes stenting.
Time frame: after 6 months and after 1 year
Comparison of patency of the bile duct 6 months after 1 year of stenting. Patency is defined as the presence of normal liver function test (direct bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transpeptidase (gamma-GT), alkaline phosphatase) and non-dilated bile ducts on Magnetic resonance cholangiopancreatography (MRCP). In the presence of cytomegalovirus (CMV) infection, rejection or other causes of possible disturbed liver function parameters, the MRCP findings rule over the lab tests.
4 secondary outcomes
safety of the Kaffes stent
Time frame: during a period of 1 year
Duration of hospitalization
Time frame: during a period of 1 year
Number of stent changes
Time frame: during a period of 1 year
Comparison of costs between normal stenting and Kaffes stenting.
Time frame: during a period of 1 year
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 15 Dec 2022.
- Related InfoLink provided by the sponsor.
Related trials for Biliary Strictures Post Liver Transplantation
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Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation
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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.
Hans Van Vlierberghe, Ph.D., M.D. principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plastic stenting and Kaffes stenting in people with Biliary Strictures Post Liver Transplantation, run by University Hospital, Ghent at 1 site in Belgium.
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 8 inclusion and 4 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 15 Dec 2022. 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 Belgium. 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?
Comparison of patency of the bile duct between normal and Kaffes stenting. (time frame: after 6 months and after 1 year). 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 15 Dec 2022.