Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis: A Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• The patients diagnosed with mild and moderate acute cholangitis based on TG 18
• Planned for ERCP within 48 hours
• 18 years old and above
Locations
Other Locations
Malaysia
Hospital Canselor Tuanku Muhriz UKM
RECRUITING
Cheras
Contact Information
Primary
Tiew Toot Chaw
warrentiew@gmail.com
+60176175253
Backup
Azlanudin Azman
drazlan@ppukm.ukm.my
+60192817878
Time Frame
Start Date: 2024-07-09
Estimated Completion Date: 2026-07-08
Participants
Target number of participants: 172
Treatments
Experimental: Gentamicin arm
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.
Active_comparator: Distilled water arm
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.
Related Therapeutic Areas
Sponsors
Leads: National University of Malaysia