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NOT YET RECRUITING
NCT07379749
NA

Impact of Positive Bile Cultures on Plastic Biliary Stent Exchange

Sponsor: Clinical Hospital Colentina

View on ClinicalTrials.gov

Summary

This prospective, unicenter, randomized controlled trial evaluates whether a positive bile culture at index ERCP with plastic stenting identifies patients who benefit from earlier stent exchange. Patients with no previous history of sphincterotomy and positive bile cultures after an ERCP will be randomized to stent exchange at 1 month versus 3 months to assess whether personalized scheduling reduces early stent occlusion and secondary acute cholangitis.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-02

Completion Date

2027-02

Last Updated

2026-01-30

Healthy Volunteers

No

Interventions

OTHER

stent exchange

standard stent exchange at three months according to the institutional norms

OTHER

Scheduled biliary stent exchange at one month

Patients within the active arm will have scheduled stent exchange at one month, in comparison to those in the control arm, which will have scheduled stent exchange at three months, according to the institutional norms in place

Locations (1)

Colentina Clinical Hospital

Bucharest, Bucharest, Romania