Impact of Positive Bile Cultures on Plastic Biliary Stent Exchange

NCT07379749 | Not Yet Recruiting

• 1 other identifier: 42/12.12.2025
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Cholangitis

Keywords

early onset acute cholangitis after subsequent biliary stent occlusion

Outcome Measures

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.

  from enrollment to the end of treatment at three months

Study Arms (2)

Control

OTHER

standard follow up and stent exchange according to institutional norm

Other: stent exchange

rapid exchange

ACTIVE COMPARATOR

rapid call back in case of positive bile culture

Other: Scheduled biliary stent exchange at one month

Interventions

stent exchange OTHER

standard stent exchange at three months according to the institutional norms

Control

Scheduled biliary stent exchange at one month OTHER

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

rapid exchange

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinical Hospital Colentina: lead

Study Sites (1)

Colentina Clinical Hospital

Bucharest, Bucharest, 021025, Romania

Location

Central Study Contacts

Bogdan R. Mateescu, Prof. M.D., Ph.D

CONTACT

21 317 3245; bogmateescu@gmail.com

Andrei M. Voiosu, M.D., PhD.

CONTACT

21 317 3245; andreivoiosu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Dr.

Model Details: 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

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: January 30, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)