A Phase 2 interventional study of Gentamicin - single dose and Distilled water in Acute Cholangitis, Biliary Tract Infection and Biliary Obstruction, sponsored by National University of Malaysia. Recruiting at 1 site in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by National University of Malaysia · Phase 2, Interventional, and Treatment
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.
82 studies on the registry are indexed under Cholangitis; 17 are open to participants now.
This study's planned enrollment of 172 is above the median of 100 across 52 interventional studies indexed under Cholangitis.
Browse Cholangitis studies →National University of Malaysia is the lead sponsor of 124 studies on the registry; 45 are open to participants now.
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In all cases of interventional ERCP, the endoscopist will routinely administer 20cc of distilled water into the bile duct before insertion of the biliary stent or, in cases where a stent is not indicated, before withdrawal of the cannulation catheter from the bile duct to flush out remaining contrast material, sludge, or debris from the bile duct. In this study, the subjects will instead be randomized to receive either 20cc of distilled water as per usual protocol (control arm) or 20cc of intraductal antibiotic (study arm). Patients will receive intraductal antibiotic Gentamicin 80mg(2ml) diluted in 20cc distilled water during ERCP.
Drug: Gentamicin - single dose
In all cases of interventional ERCP, the endoscopist will routinely administer 20cc of distilled water into the bile duct before insertion of the biliary stent or, in cases where a stent is not indicated, before withdrawal of the cannulation catheter from the bile duct to flush out remaining contrast material, sludge, or debris from the bile duct. In this study, the subjects will instead be randomized to receive either 20cc of distilled water as per usual protocol (control arm) or 20cc of intraductal antibiotic (study arm). Patients will receive intraductal distilled water 20cc during ERCP.
Drug: Distilled water
Administration described in arm/group description
Administration 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.
Time frame: Evaluated at specific timepoints at admission, on the day of ERCP (pre-procedure), and daily from Day 1 to Day 3 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.
Time frame: From hospital admission through hospital discharge during the index hospitalization (up to approximately 30 days).
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.
Time frame: From initiation of intravenous antibiotic therapy after hospital admission through discontinuation of intravenous antibiotics during the index hospitalization (up to approximately 30 days).
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.
Time frame: Evaluated at specific timepoints during the procedure until day 3 following ERCP.
Plan to share: Undecided
Started Jul 2024 (actual). Primary completion is estimated for Jul 2026, 23 months after the start.
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