Randomized Trial of Short Antibiotic Course to Decrease Post ERCP Cholangitis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Proportion of patients who develop Post-ERCP Cholangitis as defined by the revised Tokyo criterion.
研究概览
简要总结
Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopic procedure used to treat bile duct stones, obstructive jaundice, biliary leaks, and a variety of other conditions.
There is active debate whether antibiotics should be given prophylactically for ERCP outside of high risk indications including primary sclerosing cholangitis. In part this is due to a lack of appropriately powered clinical trials with adequate follow up. The aim will be to assess whether prophylactic antibiotics decrease the rate of post ERCP cholangitis as defined by the Revised Tokyo Criterion.
详细描述
OBJECTIVES AND PURPOSE
The aim is to determine whether a brief course of antibiotics following therapeutic ERCP can reduce post-ERCP cholangitis in patients for whom antibiotics are not already indicated.
STUDY DESIGN
The study will be a prospective, randomized trial consisting of 452 patients who are scheduled to undergo therapeutic ERCP at the LAC+USC Medical Center for standard indications. Patients undergoing ERCP for therapy of bile duct problems including choledocholithiasis, malignant obstruction, jaundice, and bile leak will be eligible. Those with mandatory antibiotic requirement will be excluded.
Patients will be randomly assigned in a 1:1 ratio using a computer generated randomization schedule and allocation will be concealed.
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, Investigator)
盲法说明
subjects to be randomized into two arms: antibiotic arm and no antibiotic arm
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 90 years undergoing therapeutic ERCP for standard, biliary indications including but not limited to:
- •suspected bile duct stones
- •malignant and benign biliary obstruction
- •bile leaks
排除标准
- •Patients who are incarcerated
- •Patients who are not competent to give informed consent
- •Patients in whom periprocedural antibiotics are mandatory.
- •These include patients with:
- •primary sclerosing cholangitis,
- •multiple biliary strictures,
- •hilar tumors,
- •neutropenia (absolute neutrophil count <500), or
- •immunosuppressive therapy.
- •Patients who have been diagnosed with cholangitis or are suspected to have another active infection requiring antibiotics (such as an infected fluid collection).
- •Patients who have received antibiotics within 7 days.
- •Patient who have undergone ERCP within 30 days.
- •Patients who undergo multiple ERCP for clinical indication will only be eligible to participate in the study for one procedure.
- •Patients who have had prior biliary surgeries.
- •Patients in whom bile duct decompression is unsuccessful will be excluded as these patients are at increased risk of cholangitis.
- •Patients with immediate procedural complications such as a bowel perforation.
- •Patients undergoing ERCP for diagnostic purposes only will be excluded as the aim is to study the role of antibiotics in those undergoing therapeutic ERCP.
- •Pregnant women
- •Patient with allergies to fluoroquinolones. Patient with allergies to cephalosporins or penicillin's may receive fluoroquinolones if they are randomized to antibiotics arm.
- •Patients with renal insufficiency (creatinine clearance <80ml50ml/minute), in whom dose modifications are necessary.
- •Withdrawal Criteria:
- •Patients who withdraw consent will be withdrawn from the study.
研究组 & 干预措施
Antibiotic arm
The drugs ceftriaxone and levofloxacin will be administered to patients in the antibiotic arm.
干预措施: Ceftriaxone (Drug)
Antibiotic arm
The drugs ceftriaxone and levofloxacin will be administered to patients in the antibiotic arm.
干预措施: Levofloxacin (Drug)
结局指标
主要结局
Proportion of patients who develop Post-ERCP Cholangitis as defined by the revised Tokyo criterion.
时间窗: 1 week
The primary outcome will be the proportion of patients who develop develop post-ERCP cholangitis as defined by the Revised Tokyo criterion within 1 week of ERCP.
次要结局
- Proportion of patients who develop adverse events of antibiotics(1 week)
- Days of hospitalization(1 week)
研究者
James Buxbaum
Chief Endoscopist/Associate Professor of Clinical Medicine
University of Southern California