Ignite Creation Date:
2024-05-05 @ 11:41 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01398917
Status:
UNKNOWN
Last Update Posted:
2012-07-09
First Post:
2011-04-25
Brief Title:
Short-term Stenting Versus Balloon Dilatation for Dominant Strictures in Primary Sclerosing Cholangitis
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Multicenter Randomized Trial Comparing Short-term Stenting Versus Balloon Dilatation for Dominant Strictures in Primary Sclerosing Cholangitis
Status:
UNKNOWN
Status Verified Date:
2012-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 parametersendpoints
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 05 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
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 parametersendpoints
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 05 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL3445401810 | REGISTRY | CCMO Netherlands | None |