Intraductal antibiotic given during ERCP for acute cholangitis
Official title: Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis: A Randomized Controlled Trial
Run by National University of Malaysia · NCT07407491 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 172 (estimated) |
| Sponsor | National University of Malaysia Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Cheras, Kuala Lumpur) |
| Status | Recruiting |
| Started | July 9, 2024 |
| Main results expected | July 8, 2026 |
| Study ends | July 8, 2026 |
| Registry record updated | February 12, 2026 |
| Trial ID | NCT07407491 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Endoscopic Ultrasound-Guided Hepaticogastrostomy With or Without Antegrade Stenting for Malignant Distal Biliary Obstruction
This trial tests whether adding antegrade stenting to EUS-guided hepaticogastrostomy helps longer-lasting relief of malignant distal biliary obstruction compared with hepaticogastrostomy alone in adults who cannot have ERCP.
-
Hyoscine Butylbromide During Transcystic Papillary Balloon Dilation for Choledocholithiasis
This study tests whether giving hyoscine butylbromide during laparoscopic transcystic papillary balloon dilation helps patients with common bile duct stones by making the procedure faster or easier.
-
EUS-guided pancreaticobiliary procedures with the RIVOS access device
This study tests how the RIVOS EUS access device performs during interventional procedures for pancreatic and bile duct problems in adults.
-
Composite way to measure treatment success in acute cholangitis with biliary drainage
This study tests a new composite index to measure how well treatment works for adults with acute cholangitis who undergo biliary drainage.
-
Sedation Methods in PTBD: How Two Regimens Compare for Quality and Recovery
This study tests two sedation plans (propofol with remifentanil vs propofol with ketamine) to see which helps patients recover faster after PTBD while staying comfortable and safe.
-
12-mm Partially Covered vs Bare Self-Expandable Stents for Malignant Distal Biliary Obstruction
This study tests whether a 12-mm partially covered self-expandable stent works better than a 12-mm bare self-expandable stent for patients with unresectable malignant distal biliary obstruction who have already had PTBD.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.