Short-term Stenting Versus Balloon Dilatation for Dominant Strictures in Primary Sclerosing Cholangitis

NCT ID: NCT01398917

Last Updated: 2012-07-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2015-05-31

Brief 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. 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:

1. Difference in re-intervention free survival time between both groups at two years.

2. Change in semi-quantitative scoring of cholestatic symptoms (pruritus, right upper quadrant pain, fatigue) from baseline at three months.

3. Change in total bilirubin, alkaline phosphatase, and yGT from baseline at 3 months.

4. 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

Keywords

psc; dominant stricture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

short-term stenting

one 10 Fr Plastic endoprosthesis or 2 7 Fr plastic endoprosthesis inserted through dominant stricture(s), to be extracted after 1-2 weeks

Group Type: ACTIVE_COMPARATOR

plastic endoprosthesis

Intervention Type: PROCEDURE

one 10 Fr Plastic endoprosthesis or 2 7 Fr plastic endoprosthesis inserted through dominant stricture(s), to be extracted after 1-2 weeks

balloon dilatation

4 cm 6 mm biliary dilatation balloon to be inflated for 2 minutes in dominant stricture(s)

Group Type: ACTIVE_COMPARATOR

balloon dilatation

Intervention Type: PROCEDURE

4 cm 6 mm biliary dilatation balloon to be inflated for 2 minutes in dominant stricture(s)

Interventions

plastic endoprosthesis

one 10 Fr Plastic endoprosthesis or 2 7 Fr plastic endoprosthesis inserted through dominant stricture(s), to be extracted after 1-2 weeks

Intervention Type: PROCEDURE

balloon dilatation

4 cm 6 mm biliary dilatation balloon to be inflated for 2 minutes in dominant stricture(s)

Intervention Type: PROCEDURE

Other Intervention Names

plastic stent; biliary dilatation balloon

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

C.Y. Ponsioen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cyriel Y Ponsioen, dr.

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Locations

UZLeuven

Leuven, , Belgium

Site Status: RECRUITING

Academic Medical Center

Amsterdam, , Netherlands

Site Status: RECRUITING

Rikshospitalet

Oslo, , Norway

Site Status: RECRUITING

Karolinska Institute

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Belgium; Netherlands; Norway; Sweden

Central Contacts

Cyriel Y Ponsioen, Dr.

Role: CONTACT

Phone: +31 20 5666012

Email: c.y.ponsioen@amc.nl

Florien M Toxopeus, Drs.

Role: CONTACT

Phone: +31 20 5663005

Email: f.m.toxopeus@amc.nl

Facility Contacts

Werner van Steenbergen, Prof

Role: primary

Natalie van den Ende, BsC

Role: backup

Cyriel Ponsioen, MD PhD

Role: primary

Florien Toxopeus, MsC

Role: backup

Lars Aabakken, Prof.

Role: primary

Vemund Paulsen, MD

Role: backup

Annika Bergquist, prof

Role: primary

Urban Arnelo, dr

Role: backup

References

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.

Reference Type: DERIVED

PMID: 29803836 (View on PubMed)

Other Identifiers

NL34454.018.10

Identifier Type: REGISTRY

Identifier Source: secondary_id

DILSTENT2

Identifier Type: -

Identifier Source: org_study_id