Multicenter randomized trial comparing short-term stenting versus balloon dilatation for dominant strictures in primary sclerosing cholangitis

Multicenter randomized trial comparing short-term stenting versus balloon dilatation for dominant strictures in primary sclerosing cholangitis - Dilstent 2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38315

Enrollment

Registered

2011-02-01

Start date

2011-07-22

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

inflammation of the bile ducts Primary Sclerosing Cholangitis

Interventions

During ERCP half of the subjects will receive a stent to treat the dominant stricture and the other half will have the stricture strechted out with a dilating balloon.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: PSC 18-75 years progression cholestatic complaints elevated total bilirubin and alkaline phosphatase

Exclusion criteria

Exclusion criteria: advanced PSC suppurative cholangitis malignancy

Design outcomes

Primary

Measure	Time frame
The main outcome of the study is the difference in re-intervention free survival time between both groups.	—

Secondary

Measure	Time frame
The comparison between both groups of efficacy with regard to the improvement of cholestatic symptoms, biochemical cholestasis, and quality of life. To compare the safety of a single balloon dilatation session with short-term stenting.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)