Primary Sclerosing CholangitisPhase 3NCT01398917
Short-term Stenting Versus Balloon Dilatation for Dominant Strictures in Primary Sclerosing Cholangitis
A Phase 3 study testing plastic endoprosthesis and balloon dilatation in people with Primary Sclerosing Cholangitis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 4 sites in 4 countries.
Trial summary
Primary sclerosing cholangitis (PSC) is a chronic inflammatory disease of the biliary tract of unknown origin. Around 50% of patients develop during their disease course narrowing of the main bile duct with corresponding increase in symptoms such as itching, jaundice and abdominal pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Sclerosing Cholangitis
- What is being tested?
- plastic endoprosthesis and balloon dilatation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesin 4 countries
- Study dates
- May 2011to May 2015
- Phase
- Phase 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
- PSC ascertained with MRCP, ERCP, PTC and/or liver biopsy or
- PSC highly suspected and to be confirmed with present ERCP
- Age between 18-75 years
- Total bilirubin > 3x ULN or rsie in alkaline phosphatase or bilirubin > 50% together with increase in cholestatic complaints
Who cannot join
- Prior stenting or balloon-dilatation within last 6 months
- Clinical signs serious suppurative cholangitis reflected by either fever > 39.0 °C, tachycardia, leukocytosis and elevated CRP, or fever > 38,5 C together with purulent bile found during ERCP.
- Change of ursodeoxycholic acid therapy shorter than two months ago.
- Inability to give written informed consent
- Signs of biliary cirrhosis Child-Pugh B or C
- Estimated transplant-free survival shorter than 2 years as calculated by a Mayo score < 2
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- Serious suspicion of cholangiocarcinoma, reflected by an imaging study suggestive of metastasis, MRCP with mass lesion with contrast enhancement, rise in CA19.9 of > 63 U/ml with an absolute value > 130 U/ml 14 .
- Signs of current malignancy other than basocellular skin carcinoma.
- Inability to give informed consent.
- Life expectancy < 24 months.
- Use of antibiotics in previous 4 weeks.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Belgium1 site, 1 recruiting
- Recruiting
UZLeuven
Leuven
Werner van Steenbergen, Prof, +3216340749, werner.vansteenbergen@uzleuven.be
Natalie van den Ende, BsC, +32 16340749, natalie.vandenende@uzleuven.be
Netherlands1 site, 1 recruiting
- Recruiting
Academic Medical Center
Amsterdam, 1100 DE
Cyriel Ponsioen, MD PhD, +31 20 5666012, c.y.ponsioen@amc.uva.nl
Florien Toxopeus, MsC, +31 20 5669111, f.m.toxopeus@amc.uva.nl
Norway1 site, 1 recruiting
- Recruiting
Rikshospitalet
Oslo, N-0027
Lars Aabakken, Prof., +47 23072387, lars.aabakken@medisin.uio.no
Vemund Paulsen, MD, +47 23070000, vemund.paulsen@meisin.uio.no
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institute
Stockholm, 141 86
Annika Bergquist, prof, +46 8 58582465, annika.bergquist@ki.se
Urban Arnelo, dr, +46 8 58582465, urban.arnelo@ki.se
About this study
Official title: Multicenter Randomized Trial Comparing Short-term Stenting Versus Balloon Dilatation for Dominant Strictures in Primary Sclerosing Cholangitis
Primary sclerosing cholangitis (PSC) is a chronic inflammatory disease of the biliary tract of unknown origin. Around 50% of patients develop during their disease course narrowing of the main bile duct with corresponding increase in symptoms such as itching, jaundice and abdominal pain. These narrowings can be treated by balloon dilatation or temporary insertion of a plastic endoprosthesis. However, it is not known which of these two therapeutic modalities is best. This study aims to compare both techniques in order to determine which is best in terms of postponing recurrence of the narrowing, safety and costs.
Read the detailed description
Rationale:
Primary sclerosing cholangitis is a chronic progressive fibro-obliterative disease of the biliary tree leading to biliary cirrhosis. During its course, dominant strictures occur in approximately 50% of patients. These can be accompanied by lead worsening of symptoms and jaundice and are an indication for endoscopic treatment. The best form of treatment, either balloon dilatation or short-term stent placement, has never been formally investigated.
Objective:
Primary:
To compare the efficacy of single session balloon dilatation versus short-term stent placement in non-advanced PSC patients with regard to re-intervention free recurrence rate at two years.
Secondary:
To compare the short term efficacy of single balloon dilatation versus short-term stenting with regard to improvement of cholestatic symptoms, biochemical cholestasis, and quality of life in non-endstage PSC patients at three months; to compare the safety of single balloon dilatation session versus short-term stenting in non advanced PSC patients during two years.
Study design: This is a multicenter, open-label, randomized intervention study.
Study population:
Non-advanced primary sclerosing cholangitis subjects with progression of cholestatic complaints from the outpatient population of the seven participating centres.
Main study parameters/endpoints:
- Difference in re-intervention free survival time between both groups at two years.
- Change in semi-quantitative scoring of cholestatic symptoms (pruritus, right upper quadrant pain, fatigue) from baseline at three months.
- Change in total bilirubin, alkaline phosphatase, and yGT from baseline at 3 months.
- Safety: adverse events, clinical laboratory values, vital signs.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Currently, both interventions belong to standard patient care armamentarium. Burden for the patient exists in slightly more regular follow-up visits for two years (three-monthly instead of every 3-4 months) to their treating centre. ERCP is associated with a low mortality (<0.5 %) and acceptable morbidity (overall 5%). Most dreaded complications are severe post-ERCP pancreatitis (<2%) and suppurative cholangitis (<2%). From the available retrospective literature data the incidence of these complications does not seem to differ between the two treatment modalities. ERCP will only be performed when there is a clearcut clinical indication anyway.
- Conditions
- Primary Sclerosing Cholangitis
- Being tested
- plastic endoprosthesis, balloon dilatation
- Keywords
- psc, dominant stricture
- Medical subject headings
- Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plastic endoprosthesisProcedure or surgery
Also called plastic stent
one 10 Fr Plastic endoprosthesis or 2 7 Fr plastic endoprosthesis inserted through dominant stricture(s), to be extracted after 1-2 weeks
balloon dilatationProcedure or surgery
Also called biliary dilatation balloon
4 cm 6 mm biliary dilatation balloon to be inflated for 2 minutes in dominant stricture(s)
| Study group | Role | What they receive |
|---|---|---|
| short-term stenting | Active comparator | one 10 Fr Plastic endoprosthesis or 2 7 Fr plastic endoprosthesis inserted through dominant stricture(s), to be extracted after 1-2 weeks Receives: Procedure: plastic endoprosthesis |
| balloon dilatation | Active comparator | 4 cm 6 mm biliary dilatation balloon to be inflated for 2 minutes in dominant stricture(s) Receives: Procedure: balloon dilatation |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence-free interval of the primary dominant stricture
Measured: 24 months
Secondary outcomes (1)
number of patients with adverse events in both groups
adverse events within first 3 months after the intervention
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Sclerosing CholangitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, C.Y. Ponsioen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Cyriel Y Ponsioen, dr., Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398917
- Sponsor's protocol ID
- DILSTENT2
- Other IDs
- NL34454.018.10
- Status last verified
- Jul 2012
- First submitted
- 25 Apr 2011
- Last updated
- 9 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ponsioen CY, Arnelo U, Bergquist A, Rauws EA, Paulsen V, Cantu P, Parzanese I, De Vries EM, van Munster KN, Said K, Chazouilleres O, Desaint B, Kemgang A, Farkkila M, Van der Merwe S, Van Steenbergen W, Marschall HU, Stotzer PO, Thorburn D, Pereira SP, Aabakken L. No Superiority of Stents vs Balloon Dilatation for Dominant Strictures in Patients With Primary Sclerosing Cholangitis. Gastroenterology. 2018 Sep;155(3):752-759.e5. doi: 10.1053/j.gastro.2018.05.034. Epub 2018 May 24.
PubMed 29803836
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Trial Comparing Short-term Stenting Versus Balloon Dilatation for Dominant Strictures in Primary Sclerosing Cholangitis
- ClinicalTrials.gov ID
- NCT01398917
- Acronym / sponsor ID
- DILSTENT2
- Conditions
- Primary Sclerosing Cholangitis
- Keywords
- psc, dominant stricture
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- May 2011
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 21 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.
Primary sclerosing cholangitis (PSC) is a chronic inflammatory disease of the biliary tract of unknown origin. Around 50% of patients develop during their disease course narrowing of the main bile duct with corresponding increase in symptoms such as itching, jaundice and abdominal pain. These narrowings can be treated by balloon dilatation or temporary insertion of a plastic endoprosthesis. However, it is not known which of these two therapeutic modalities is best. This study aims to compare both techniques in order to determine which is best in terms of postponing recurrence of the narrowing, safety and costs.
Detailed description
Rationale:
Primary sclerosing cholangitis is a chronic progressive fibro-obliterative disease of the biliary tree leading to biliary cirrhosis. During its course, dominant strictures occur in approximately 50% of patients. These can be accompanied by lead worsening of symptoms and jaundice and are an indication for endoscopic treatment. The best form of treatment, either balloon dilatation or short-term stent placement, has never been formally investigated.
Objective:
Primary:
To compare the efficacy of single session balloon dilatation versus short-term stent placement in non-advanced PSC patients with regard to re-intervention free recurrence rate at two years.
Secondary:
To compare the short term efficacy of single balloon dilatation versus short-term stenting with regard to improvement of cholestatic symptoms, biochemical cholestasis, and quality of life in non-endstage PSC patients at three months; to compare the safety of single balloon dilatation session versus short-term stenting in non advanced PSC patients during two years.
Study design: This is a multicenter, open-label, randomized intervention study.
Study population:
Non-advanced primary sclerosing cholangitis subjects with progression of cholestatic complaints from the outpatient population of the seven participating centres.
Main study parameters/endpoints:
- Difference in re-intervention free survival time between both groups at two years.
- Change in semi-quantitative scoring of cholestatic symptoms (pruritus, right upper quadrant pain, fatigue) from baseline at three months.
- Change in total bilirubin, alkaline phosphatase, and yGT from baseline at 3 months.
- Safety: adverse events, clinical laboratory values, vital signs.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Currently, both interventions belong to standard patient care armamentarium. Burden for the patient exists in slightly more regular follow-up visits for two years (three-monthly instead of every 3-4 months) to their treating centre. ERCP is associated with a low mortality (<0.5 %) and acceptable morbidity (overall 5%). Most dreaded complications are severe post-ERCP pancreatitis (<2%) and suppurative cholangitis (<2%). From the available retrospective literature data the incidence of these complications does not seem to differ between the two treatment modalities. ERCP will only be performed when there is a clearcut clinical indication anyway.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short-term stenting | Active comparator | Procedure: plastic endoprosthesisone 10 Fr Plastic endoprosthesis or 2 7 Fr plastic endoprosthesis inserted through dominant stricture(s), to be extracted after 1-2 weeks |
| balloon dilatation | Active comparator | Procedure: balloon dilatation4 cm 6 mm biliary dilatation balloon to be inflated for 2 minutes in dominant stricture(s) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- PSC ascertained with MRCP, ERCP, PTC and/or liver biopsy or
- PSC highly suspected and to be confirmed with present ERCP
- Age between 18-75 years
- Total bilirubin > 3x ULN or rsie in alkaline phosphatase or bilirubin > 50% together with increase in cholestatic complaints
Key exclusion criteria (11 listed)
- Prior stenting or balloon-dilatation within last 6 months
- Clinical signs serious suppurative cholangitis reflected by either fever > 39.0 °C, tachycardia, leukocytosis and elevated CRP, or fever > 38,5 C together with purulent bile found during ERCP.
- Change of ursodeoxycholic acid therapy shorter than two months ago.
- Inability to give written informed consent
- Signs of biliary cirrhosis Child-Pugh B or C
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 endoprosthesisAlso: plastic stentone 10 Fr Plastic endoprosthesis or 2 7 Fr plastic endoprosthesis inserted through dominant stricture(s), to be extracted after 1-2 weeks | Procedure or surgery | short-term stenting |
| balloon dilatationAlso: biliary dilatation balloon4 cm 6 mm biliary dilatation balloon to be inflated for 2 minutes in dominant stricture(s) | Procedure or surgery | balloon dilatation |
Primary outcome
recurrence-free interval of the primary dominant stricture
Time frame: 24 months
1 secondary outcome
number of patients with adverse events in both groups
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2012.
- Derived from this study: PubMed 29803836Ponsioen CY, Arnelo U, Bergquist A, Rauws EA, Paulsen V, Cantu P, Parzanese I, De Vries EM, van Munster KN, Said K, Chazouilleres O, Desaint B, Kemgang A, Farkkila M, Van der Merwe S, Van Steenbergen W, Marschall HU, Stotzer PO, Thorburn D, Pereira SP, Aabakken L. No Superiority of Stents vs Balloon Dilatation for Dominant Strictures in Patients With Primary Sclerosing Cholangitis. Gastroenterology. 2018 Sep;155(3):752-759.e5. doi: 10.1053/j.gastro.2018.05.034. Epub 2018 May 24.
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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.
Cyriel Y Ponsioen, dr. principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing plastic endoprosthesis and balloon dilatation in people with Primary Sclerosing Cholangitis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 4 sites in 4 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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 9 Jul 2012. 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 Belgium, Netherlands, Norway, Sweden. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cyriel Y Ponsioen, Dr. (+31 20 5666012, c.y.ponsioen@amc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence-free interval of the primary dominant stricture (time frame: 24 months). 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 NCT01398917, which also lists 1 linked publication.
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 9 Jul 2012; AzTrials last refreshed its copy on 1 Nov 2026.