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?
The patients diagnosed with mild and moderate acute cholangitis based on TG 18
Planned for ERCP within 48 hours
18 years old and above
Severe acute cholangitis
History of antibiotic hypersensitivity
Receiving cancer chemotherapy, steroids, or immunosuppressive agents
Concomitant infections
Parallel
Gentamicin - single dose
DrugAdministration described in arm/group description
Distilled water
DrugAdministration described in arm/group description
To evaluate the efficacy of local intraductal antibiotic administration during ERCP in patients with acute cholangitis, as assessed by resolution of clinical symptoms and improvement in inflammatory markers and liver function tests.
1. Change in Inflammatory Markers: Reduction in total white cell count (WCC), expressed in ×10⁹/L, and C-reactive protein (CRP), expressed in mg/L, measured from baseline (pre-ERCP) to 24-72 hours post-ERCP. 2. Change in Liver Function Tests: Improvement in liver function parameters including total bilirubin (µmol/L), direct bilirubin (µmol/L), alkaline phosphatase (ALP; U/L), alanine aminotransferase (ALT; U/L), aspartate aminotransferase (AST; U/L), and international normalized ratio (INR), measured from baseline (pre-ERCP) to 24-72 hours post-ERCP. 3. Change in Vital Signs: Serial improvement in vital signs, including body temperature (°C), blood pressure (mmHg), and pulse rate (beats per minute), measured from baseline (pre-ERCP) to 72 hours following ERCP.
To compare the length of hospital stay
Total duration of hospitalization, calculated as the number of days from the date of hospital admission to the date of hospital discharge following the index ERCP procedure.
To compare the duration of intravenous antibiotic therapy.
Criteria for intravenous to per oral switch antibiotic: * Able to tolerate oral therapy * No vomiting or diarrhea or nil by mouth * Clinical improvement with temperature less than 38°C, systolic blood pressure \>90 mmHg, heart rate \<100 beats per minute, and normal white blood cell count or a decrease of at least 2x10\^9/L over the last 24 hours.
To compare the number of participants that developed a peri-procedural complication.
Peri-procedural complications assessed by post-ERCP monitoring, including pancreatitis, procedure-related bleeding, cardiopulmonary complications, gastrointestinal perforation, and sedation-related adverse events, recorded until day 3 following ERCP.
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