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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
stent exchange
Other interventionstandard stent exchange at three months according to the institutional norms
Scheduled biliary stent exchange at one month
Other interventionPatients 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
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: ControlOther 1 intervention
Group B: rapid exchangeActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Comparative analysis of the incidence rates of acute cholangitis in the scheduled stent exchange group, at one month, vs. standard stent exchange at three months
The primary endpoint of this study is the incidence of cholangitis in patients with a positive bile culture at index ERCP with plastic stent placement. By comparing the outcomes between the 2 groups, the study aims to demonstrate that earlier stent exchange in this high-risk subgroup improves patient outcome by decreasing procedure-related complications, supporting a personalized management strategy instead of the current standard.
Time frame
from enrollment to the end of treatment at three monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: