Clinical Trial

Impact of Positive Bile Cultures on Plastic Biliary Stent Exchange

Study acronym: TEMPEST 2
Not Yet Recruiting
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.
Trial Details
NCT Number NCT07379749
Lead Sponsor Clinical Hospital Colentina
Conditions Acute Cholangitis
Enrollment 140 participants
Start Date 2026-02
Primary Completion 2026-12 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2026-01-30