NCT07455227尚未招募不适用
Comparison of Endoscopic Sphincterotomy and Conservative Management in Mild Gallstone-Induced Pancreatitis Patients Declining Subsequent Cholecystectomy : a Randomized Control Trial.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- recurrent pancreatitis
研究概览
简要总结
to investigate the role and potential benefits or drawbacks of ERCP with sphincterotomy in patients declining subsequent cholecystectomy for gallstone-induced pancreatitis.
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
- None
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
- •Diagnosis of gallstone-related pancreatitis (classified as mild pancreatitis according to the 2012 revised Atlanta classification and definitions).
- •Imaging studies reveal the presence of gallstones or sludge, along with at least one of the following conditions: i. Imaging evidence of common bile duct dilation (common bile duct diameter > 8 mm for patients aged ≤ 75 years; > 10 mm for patients aged > 75 years).
- •ii. Biochemical evidence of cholestasis with total bilirubin levels between 1.8 - 4 mg/dL.
- •iii. Alanine aminotransferase (ALT) levels greater than twice the upper limit of normal.
排除标准
- 未提供
研究组 & 干预措施
Placebo
No Intervention
ERCP
Experimental
干预措施: ERCP (Procedure)
结局指标
主要结局
recurrent pancreatitis
时间窗: 1 year
次要结局
未报告次要终点
研究者
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