A Single-Center, Prospective, Randomized, Controlled, Exploratory Trial Comparing the Efficacy and Safety of Parecoxib vs. Indomethacin in Preventing Post-ERCP Pancreatitis: The PRECISE Trail
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Incidence of Post-ERCP Pancreatitis (PEP)
研究概览
简要总结
This study aims to evaluate the efficacy and safety of parecoxib versus indomethacin in preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). It is a single-center, prospective, randomized, controlled, exploratory trial. Participants will be randomly assigned to receive either parecoxib or indomethacin as a preventive treatment. The primary endpoint is to compare the efficacy of the two drugs in reducing the incidence of PEP. Secondary endpoints include the incidence of moderate to severe PEP and post-ERCP-related adverse events. This study will systematically assess the efficacy and safety of both drugs, providing preliminary data for future larger confirmatory trials.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years.
- •Patients scheduled to undergo ERCP for conditions such as common bile duct stones, benign or malignant biliary strictures, cholangitis, suspected biliary tumors, unexplained jaundice, or pancreas divisum.
排除标准
- •Previous papillectomy.
- •Previous endoscopic sphincterotomy (EST) without planned pancreatic duct intervention.
- •Simple biliary stent removal or replacement without planned pancreatic duct intervention.
- •Biliary-duodenal fistula, post-biliary-duodenal anastomosis, or post-biliary-jejunal anastomosis.
- •Malignant tumor of the pancreatic head.
- •Currently or recently (within 1 week) suffering from acute pancreatitis.
- •Current or recent (within 1 week) use of NSAIDs.
- •Recent (within 2 weeks) or within 4 weeks prior to surgery, gastrointestinal bleeding or peptic ulcers.
- •History of significant adverse reactions to NSAIDs.
- •Renal insufficiency (creatinine clearance < 30 mL/min).
- •Moderate to severe hepatic impairment (Child-Pugh score ≥ 7).
- •Severe cardiovascular or cerebrovascular disease.
- •Patients with psychiatric disorders.
- •Pregnant or breastfeeding patients.
- •Patients without a rectum.
- •Patients unwilling or unable to provide informed consent.
研究组 & 干预措施
Parecoxib Group
干预措施: Parecoxib Sodium (Drug)
Indomethacin Group
干预措施: Indomethacin suppository (Drug)
结局指标
主要结局
Incidence of Post-ERCP Pancreatitis (PEP)
时间窗: 24 hours after ERCP procedure.
The primary outcome is the proportion of patients who develop post-ERCP pancreatitis. PEP is characterized by new or worsened abdominal pain, elevated serum amylase levels (≥3 times the upper normal limit).
次要结局
- Incidence of Moderate to Severe PEP(At discharge (up to 30 days))
- Incidence of Hyperamylasemia(3 and 24 hours after ERCP procedure)
- Post-Procedure Discomfort Symptoms(Baseline (pre-procedure), 3 hours post-procedure, 6 hours post-procedure, 12 hours post-procedure, 24 hours post-procedure, 48 hours post-procedure, 72 hours post-procedure, and at discharge (up to 30 days))
- Bleeding, Perforation, Cholangitis, Cardiac Adverse Events, Renal Adverse Events(3 hours post-procedure, 6 hours post-procedure, 12 hours post-procedure, 24 hours post-procedure, 48 hours post-procedure, 72 hours post-procedure, and at discharge (up to 30 days))
研究者
Ge Yu
Attending Physician, Gastroenterology Department
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine