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Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis: A Randomized Controlled Trial
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?
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur, Malaysia
Start Date
July 9, 2024
Primary Completion Date
July 8, 2026
Completion Date
July 8, 2026
Last Updated
February 12, 2026
172
ESTIMATED participants
Gentamicin - single dose
DRUG
Distilled water
DRUG
Lead Sponsor
National University of Malaysia
NCT05169398
NCT06620328
NCT07108725
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