Impact of Positive Bile Cultures on Plastic Biliary Stent Exchange

Starting soon · Not applicable

Conditions studied: Acute Cholangitis

In brief

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 facts

Study ID

NCT07379749

Run by

Clinical Hospital Colentina

People needed

140

Starts

2026-02-01

Expected to finish

2027-02-01

Last updated by the study team

2026-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients between 18 and 90 years old with native papilla and obstructive jaundice of any etiology requiring plastic biliary stent placement, with a positive bile culture at index ERCP who can provide written informed consent (obtained from the patient or legal caregiver).

You may not qualify if…

• prior ERCP attempts
• patients with bilio-digestive surgical or endoscopic anastomoses
• inability to provide informed consent due to cognitive, legal, or medical reasons
• scheduled surgical resection within one month after ERCP.

Where it is running

• Colentina Clinical Hospital — Bucharest, Bucharest, Romania

Full record on ClinicalTrials.gov

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