Diclophenac Potassium Versus Ceftazidime for Reduction of Post ERCP Pancreatitis in Average Risk Patients-double Blind, Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Incidence of PEP in the group of patients receiving Ceftazidime versus incidence of PEP in the group of patients receiving Diclophenac potassium
研究概览
简要总结
Diclophenac potassium and ceftazidime are commercially available drugs that are used in various clinical situations. They are safe and known for years. Diclophenac potassium and Ceftazidime have been used in some studies for the prophylaxis and treatment of pancreatitis and Post-ERCP Pancreatitis (PEP). Diclophenac potassium, together with indometacin is currently standard treatment for prevention of (PEP) while ceftazidime is possible alternative treatment for patients with contraindications for nonsteroidal medicines. The aim of the study is to evaluate the efficacy of Ceftazidime for the prophylaxis of PEP.
详细描述
Study type:
Interventional Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: only Investigator Primary Purpose: Prevention Study Phase: Phase 4
Conditions or Focus of the study: Post ERCP pancreatitis
Intervention information
- Intervention Names ERCP
- Arm Information
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •o All patients undergone to ERCP irrespectively about the diagnosis
排除标准
- •o Unwillingness or inability to consent for the study
- •Age < 18 years
- •Previous ERCP (papillotomy)
- •Intrauterine pregnancy
- •Breast feeding mother
- •Allergy to Aspirin or NSAIDs and Ceftazidime
- •NSAID or antibiotic use within 1 week (ASA 325 mg daily or less acceptable)
- •Renal failure (Cr > 1.4)
- •Active or recent (within 4 weeks) gastrointestinal hemorrhage
- •Existing acute pancreatitis (lipase peak) within 72 hours prior to ERCP
- •Anticipated inability to follow protocol
研究组 & 干预措施
Ceftazidime plus placebo
Procedure/Surgery: ERCP Each patient will receive: Ceftazidime 2 g i.v. once daily 30 minutes prior to procedure and glycerin suppository as placebo
干预措施: Ceftazidime (Drug)
Diclophenac sodium plus placebo
Procedure/Surgery:ERCP Each patient will receive 100 mg Diclophenac suppositories, once daily immediately prior to procedure plus 100 ml of saline as placebo
干预措施: Ceftazidime (Drug)
结局指标
主要结局
Incidence of PEP in the group of patients receiving Ceftazidime versus incidence of PEP in the group of patients receiving Diclophenac potassium
时间窗: One year
次要结局
未报告次要终点
研究者
Goran Hauser
Goran Hauser, MD, PhD
University Hospital Rijeka