Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Care provider and patients are blinded from knowing the group of the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients diagnosed with mild and moderate acute cholangitis based on TG 18
- •Planned for ERCP within 48 hours
- •18 years old and above
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Gentamicin - single dose (Drug)
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.
干预措施: Distilled water (Drug)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- To compare the length of hospital stay(From hospital admission through hospital discharge during the index hospitalization (up to approximately 30 days).)
- 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).)
- To compare the number of participants that developed a peri-procedural complication.(Evaluated at specific timepoints during the procedure until day 3 following ERCP.)
研究者
Prof Madya Dr. Azlanudin Azman
Associate Professor
National University of Malaysia