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Recruiting Phase 2 NCT07407491

Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis

Trial Parameters

Condition Acute Cholangitis
Sponsor National University of Malaysia
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 172
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-07-09
Completion 2026-07-08
Interventions
Gentamicin - single doseDistilled water

Brief 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?

Eligibility 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

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