Short-term Stenting Versus Balloon Dilatation for Dominant Strictures in Primary Sclerosing Cholangitis
Keywords
Abstract
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.
Dates
| Last Verified: | 06/30/2012 |
| First Submitted: | 04/24/2011 |
| Estimated Enrollment Submitted: | 07/19/2011 |
| First Posted: | 07/20/2011 |
| Last Update Submitted: | 07/04/2012 |
| Last Update Posted: | 07/08/2012 |
| Actual Study Start Date: | 04/30/2011 |
| Estimated Primary Completion Date: | 04/30/2015 |
| Estimated Study Completion Date: | 04/30/2015 |
Condition or disease
Intervention/treatment
Procedure: short-term stenting
Procedure: balloon dilatation
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: 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 | Procedure: 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 |
| Active Comparator: balloon dilatation 4 cm 6 mm biliary dilatation balloon to be inflated for 2 minutes in dominant stricture(s) | Procedure: balloon dilatation 4 cm 6 mm biliary dilatation balloon to be inflated for 2 minutes in dominant stricture(s) |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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. |
Outcome
Primary Outcome Measures
1. recurrence-free interval of the primary dominant stricture [24 months]
Secondary Outcome Measures
1. number of patients with adverse events in both groups [3 months]
