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

Clinical Hospital Colentina

Status: Not yet enrolling

Conditions: Acute Cholangitis

Treatments: Other: Scheduled biliary stent exchange at one month; Other: stent exchange

Study type: Interventional

Funder types: Other

Identifiers

NCT07379749

42/12.12.2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Control

Other group

Description:

standard follow up and stent exchange according to institutional norm

Treatment:

Other: stent exchange

rapid exchange

Active Comparator group

Description:

rapid call back in case of positive bile culture

Treatment:

Other: Scheduled biliary stent exchange at one month