ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 12
- 主要终点
- Number of participants with composite outcome of death, major complication or recurrent biliary event
研究概览
简要总结
The goal of this study is to compare safety and efficacy of laparoscopic cholecystectomy versus wait-and-see policy after endoscopic removal of common bile duct stones in elderly. The primary endpoint is a composite outcome: Death or major postoperative complications or recurrent biliary disease within 1 year after randomization.
详细描述
Elderly patients with common bile duct stones are asked to participate this randomized trial after successful endoscopic removal of common bile duct stones. The hypothesis of the study is that wait-and-see policy is non-inferior to laparoscopic cholecystectomy. Four hundred patients are randomized 1:1 to either laparoscopic cholecystectomy group or wait-and see group. Cholecystectomy is done on the same admission or within two weeks after randomization. One interim analysis is planned for the trial after 100 randomized patients to assess safety. The trial is terminated if there is a statistically significant difference in primary outcome with p<0.001 (chi-square test) between the study arms.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Common bile duct stones cleared after Endoscopic Retrograde Cholangio Pancreatography (ERCP)
- •Age >= 80 years or age 75-79 years with a Charlson Comorbidity index >=2
- •gallbladder in situ
排除标准
- •Acute Cholecystitis
- •Biliary Pancreatitis
- •Severe or moderately severe post-ERCP pancreatitis
- •Chronic pancreatitis
- •Bile duct pathology
- •Widespread malignancy
- •Unable to give consent
研究组 & 干预措施
Cholecystectomy
Laparoscopic cholecystectomy is done within 2 weeks after endoscopic removal of common bile duct stones.
干预措施: Laparoscopic cholecystectomy (Procedure)
Wait-and-see
After endoscopic removal of common bile duct stones, patients are managed non-operatively. During the follow-up cholecystectomy will be available on demand.
结局指标
主要结局
Number of participants with composite outcome of death, major complication or recurrent biliary event
时间窗: From randomization to 1 year
The primary outcome is a composite outcome including death within 1 year after randomization, the occurrence of major complications within 30 days from surgery and recurrent biliary event requiring hospitalization. within 1 year after randomization. A recurrent biliary event refers to cholecystitis, pancreatitis, cholangitis, or bile duct stones. Major complications were defined as infectious, cardiovascular and pulmonary complications, and surgical complication (Clavien-Dindo grade III or higher)
次要结局
- Number of patients with recurrent biliary event(From randomization to 1 year)
- Number of patients with uncomplicated biliary pain or post cholecystectomy pain(At 30, 180 and 365 days after randomization)
- Healthcare costs(From randomization to 1 year)
- Number of good days(From randomization to 1 year)
- EQ VAS value(at 30 days, 180 days and 365 days after randomization)
- Survival(From randomization to 1 year)
- Number of patients with major complications(From randomization to 1 year)
- Composite outcome of death or occurrence of major complications or recurrent biliary event requiring hospitalization(From randomization to 2 years)
研究者
Panu Mentula
MD, PhD, Head of Emergency Surgery
Helsinki University Central Hospital