Impact of Positive Bile Cultures on Plastic Biliary Stent Exchange
ConditionAcute Cholangitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinical Hospital Colentina
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- stent exchange
- Scheduled biliary stent exchange at one month
Treatment groups
140 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov