Trials / Recruiting
RecruitingNCT07407491
Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis
Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis: A Randomized Controlled Trial
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 172 (estimated)
- Sponsor
- National University of Malaysia · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Does intraductal administration of antibiotics during endoscopic retrograde cholangiopancreatography (ERCP), in addition to standard systemic antibiotic therapy, improve clinical outcomes in patients with acute cholangitis compared with standard systemic antibiotic therapy alone?
Detailed description
Acute cholangitis is a serious infection of the biliary system caused by biliary obstruction and infected bile, which may rapidly progress to sepsis if not promptly treated. Standard management includes systemic antibiotics and urgent biliary drainage, most commonly by endoscopic retrograde cholangiopancreatography (ERCP). However, biliary obstruction may impair biliary excretion of systemically administered antibiotics, resulting in subtherapeutic antibiotic concentrations within infected bile. Intraductal administration of antibiotics during ERCP may achieve higher local antimicrobial concentrations at the site of infection. This study evaluates the efficacy and safety of intraductal antibiotic administration during ERCP as an adjunct to standard systemic antibiotic therapy in patients with acute cholangitis.
Conditions
- Acute Cholangitis
- Biliary Tract Infection
- Biliary Obstruction
- Choledocholithiasis
- Malignant Biliary Stricture
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gentamicin - single dose | Administration described in arm/group description |
| DRUG | Distilled water | Administration described in arm/group description |
Timeline
- Start date
- 2024-07-09
- Primary completion
- 2026-07-08
- Completion
- 2026-07-08
- First posted
- 2026-02-12
- Last updated
- 2026-02-12
Locations
1 site across 1 country: Malaysia
Source: ClinicalTrials.gov record NCT07407491. Inclusion in this directory is not an endorsement.