Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis: A Randomized Controlled Trial

What this Trial Is About

Acute cholangitis is a serious infection of the biliary system caused by blockage and infected bile, which can quickly lead to sepsis if untreated. Researchers are evaluating whether adding intraductal antibiotics during endoscopic retrograde cholangiopancreatography (ERCP) improves outcomes for patients with acute cholangitis compared to standard systemic antibiotic therapy alone. This study is a phase 2 randomized controlled trial assessing the efficacy and safety of this approach. Participants will undergo ERCP where they are randomly assigned to receive either 20cc of distilled water (control) or 20cc of intraductal antibiotic Gentamicin 80mg diluted in distilled water (study arm) during the procedure. In both groups, the endoscopist will flush the bile duct with the assigned solution before placing a biliary stent or removing the catheter. All patients will continue receiving standard systemic antibiotic therapy alongside the study intervention. Throughout the study, participants will be closely monitored for symptom resolution and improvements in inflammatory markers and liver function tests from admission through Day 3 after ERCP. Researchers will also track hospital stay length, duration of intravenous antibiotics, and any complications during and after the procedure. The trial aims to measure the local antibiotic's effect on infection control and safety over approximately one month of hospitalization.

Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis