Acute Cholangitis, Biliary Obstruction, Biliary Tract Infection, Choledocholithiasis, Malignant Biliary Stricture
Conditions
Keywords
Acute Cholangitis, ERCP, Intraductal antibiotics, Biliary tract infection, Choledocholithiasis
Brief 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?
Detailed description
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.
Interventions
Administration described in arm/group description
DRUGDistilled water
Administration described in arm/group description
Sponsors
National University of Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Care provider and patients are blinded from knowing the group of the study.
Intervention model description
Patients will be randomised into the intervention or control group (Intervention group will receive intraductal antibiotic Gentamicin and control group will receive intraductal distilled water in ERCP)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patients diagnosed with mild and moderate acute cholangitis based on TG 18 * Planned for ERCP within 48 hours * 18 years old and above
Exclusion criteria
* Severe acute cholangitis * History of antibiotic hypersensitivity * Receiving cancer chemotherapy, steroids, or immunosuppressive agents * Concomitant infections * Recent biliary interventions such as percutaneous transhepatic biliary drainage (PTBD) within last 3 months * Known or suspected perforated tympanic membrane, myasthenia gravis
Design outcomes
Primary
| Measure | Time frame | 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. | Evaluated at specific timepoints at admission, on the day of ERCP (pre-procedure), and daily from Day 1 to Day 3 following ERCP. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To compare the length of hospital stay | From hospital admission through hospital discharge during the index hospitalization (up to approximately 30 days). | 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. | From initiation of intravenous antibiotic therapy after hospital admission through discontinuation of intravenous antibiotics during the index hospitalization (up to approximately 30 days). | 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. | Evaluated at specific timepoints during the procedure until day 3 following ERCP. | 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. |
Countries
Malaysia
Contacts
CONTACTTiew Toot Chaw
CONTACTAzlanudin Azman
PRINCIPAL_INVESTIGATORAzlanudin Azman
Universiti Kebangsaan Malaysia Medical Centre
Outcome results
None listed