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Impact of Positive Bile Cultures on Plastic Biliary Stent Exchange
Sponsor: Clinical Hospital Colentina
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
Conditions
Interventions
stent exchange
standard stent exchange at three months according to the institutional norms
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