Impact of Positive Bile Cultures on Plastic Biliary Stent Exchange (TEMPEST 2)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Cholangitis
• Intervention / Treatment: Other: stent exchange; Other: Scheduled biliary stent exchange at one month

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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bogdan R. Mateescu, Prof. M.D., Ph.D; Phone Number: +40 21 317 3245; Email: bogmateescu@gmail.com
• Study Contact Backup: Name: Andrei M. Voiosu, M.D., PhD.; Phone Number: +40 21 317 3245; Email: andreivoiosu@gmail.com

Study Locations

• Romania
  • Bucharest
    • Bucharest, Bucharest, Romania, 021025
      • Colentina Clinical Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control; standard follow up and stent exchange according to institutional norm	Other: stent exchange; standard stent exchange at three months according to the institutional norms
Active Comparator: rapid exchange; rapid call back in case of positive bile culture	Other: Scheduled 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	from enrollment to the end of treatment at three months

Collaborators and Investigators

• Sponsor: Clinical Hospital Colentina

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: January 23, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: early onset acute cholangitis after subsequent biliary stent occlusion
• Other Study ID Numbers: 42/12.12.2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No