Acute Cholangitis
Conditions
Keywords
early onset acute cholangitis after subsequent biliary stent occlusion
Brief 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.
Detailed description
A positive bile culture obtained at the index ERCP in patients with no previous history of sphincterotomy undergoing plastic biliary stenting may represent a key, yet currently largely ignored, predictor of early stent occlusion and subsequent acute cholangitis. Based on the findings of the TEMPEST Study, conducted in the Gastroenterology Department of Colentina Clinical Hospital (currently submitted for publication), which suggested a clinical benefit of earlier scheduled ERCP for stent exchange in this high-risk subgroup, we hypothesize that bile culture-guided scheduling of stent exchange can improve clinical outcomes. To test this hypothesis, we propose a prospective, unicentric, randomized controlled trial comparing patients with positive bile cultures at index ERCP randomized to early stent exchange at 1 month versus standard exchange at 3 months. The primary objective is to determine whether personalized scheduling based on initial bile culture results reduces the incidence of early acute cholangitis, thereby offering a simple, low-cost strategy to optimize post-ERCP management and prevent further complications.
Interventions
OTHERstent exchange
standard stent exchange at three months according to the institutional norms
OTHERScheduled 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
Sponsors
Clinical Hospital Colentina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Patients with plastic biliary stent placement and a positive bile culture at index ERCP will be randomized into two groups: Group A, scheduled for early plastic stent exchange at 1 month, and Group B, scheduled for standard stent exchange at 3 months
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | from enrollment to the end of treatment 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. |
Countries
Romania
Contacts
CONTACTBogdan R. Mateescu, Prof. M.D., Ph.D
CONTACTAndrei M. Voiosu, M.D., PhD.
Outcome results
None listed