Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis

Phase 2RecruitingNCT07407491

National University of Malaysia172 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

172

Conditions

Acute Cholangitis Biliary Tract Infection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.