Intraductal antibiotic given during ERCP for acute cholangitis
Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis: A Randomized Controlled Trial
This trial tests whether putting an antibiotic directly into the bile ducts during ERCP, together with standard IV antibiotics, helps adults with mild-to-moderate acute cholangitis recover faster and avoid worsening infection compared with IV antibiotics alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 172 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National University of Malaysia Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Cheras, Kuala Lumpur) |
| Trial ID | NCT07407491 on ClinicalTrials.gov |
What this trial studies
Acute cholangitis is usually treated with systemic antibiotics and urgent ERCP drainage, but biliary obstruction can limit antibiotic levels in the bile. This Phase 2 interventional trial compares intraductal gentamicin given during ERCP versus intraductal distilled water (placebo), each administered in addition to standard systemic antibiotic therapy. The study enrolls adults with mild-to-moderate disease who are planned for ERCP within 48 hours and excludes severe cholangitis, recent biliary interventions, immunosuppression, and certain contraindications. Outcomes focus on clinical resolution, safety, and progression to more severe infection, and the trial is conducted at Hospital Canselor Tuanku Muhriz UKM in Kuala Lumpur.
Who should consider this trial
Good fit: Adults (≥18) with mild-to-moderate acute cholangitis based on Tokyo Guidelines 2018 who are scheduled for ERCP within 48 hours and do not have severe disease or major immunosuppression.
Not a fit: Patients with severe acute cholangitis, active concomitant infections, recent biliary drainage procedures, ongoing chemotherapy or immunosuppression, or known antibiotic contraindications are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, intraductal antibiotics could speed clearance of infected bile, reduce progression to sepsis, and lower the need for additional procedures.
How similar studies have performed: Small pharmacokinetic studies and case series have shown higher bile antibiotic concentrations after intraductal dosing, but large randomized outcome trials are limited so the approach remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The patients diagnosed with mild and moderate acute cholangitis based on TG 18 * Planned for ERCP within 48 hours * 18 years old and above Exclusion Criteria: * Severe acute cholangitis * History of antibiotic hypersensitivity * Receiving cancer chemotherapy, steroids, or immunosuppressive agents * Concomitant infections * Recent biliary interventions such as percutaneous transhepatic biliary drainage (PTBD) within last 3 months * Known or suspected perforated tympanic membrane, myasthenia gravis
Where this trial is running
Cheras, Kuala Lumpur
- Hospital Canselor Tuanku Muhriz UKM — Cheras, Kuala Lumpur, Malaysia (Recruiting)
Study contacts
- Principal investigator: Azlanudin Azman — Universiti Kebangsaan Malaysia Medical Centre
- Study coordinator: Tiew Toot Chaw
- Email: warrentiew@gmail.com
- Phone: +60176175253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.