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【ChiCTR1900027713】Comparison of the safety and efficacy of single-stage ERCP plus Laparoscopic cholecystectomy versus two-stage ERCP followed by Laparoscopic cholecystectomy 6 to 8 weeks later

基本信息
登记号

ChiCTR1900027713

试验状态

结束

药物名称

/

药物类型

/

规范名称

/

首次公示信息日的期

2019-11-24

临床申请受理号

/

靶点

/

适应症

因胆石症和胆总管结石引起的阻塞性黄疸

试验通俗题目

Comparison of the safety and efficacy of single-stage ERCP plus Laparoscopic cholecystectomy versus two-stage ERCP followed by Laparoscopic cholecystectomy 6 to 8 weeks later

试验专业题目

Comparison of the safety and efficacy of single-stage ERCP plus Laparoscopic cholecystectomy versus two-stage ERCP followed by Laparoscopic cholecystectomy 6 to 8 weeks later

申办单位信息
申请人联系人
申请人名称
联系人邮箱
联系人邮编

46040

联系人通讯地址
临床试验信息
试验目的

The present study aimed to assess the feasibility of performing cholecystectomy in the same session or same hospitalization following single-stage ERCP in patients with obstructive jaundice due to cholelithiasis and choledocholithiasis.

试验分类
试验类型

随机平行对照

试验分期

其它

随机化

The cases were performed by lot by simple randomization method.

盲法

No

试验项目经费来源

No financial support in this study

试验范围

/

目标入组人数

43;39;37

实际入组人数

/

第一例入组时间

2017-10-10

试验终止时间

2018-10-10

是否属于一致性

/

入选标准

Eligibility criteria included no difficulty in ERCP, bile duct stones and cholelithiasis as demonstrated by an imaging method, no suspected or confirmed malignancy, no history of abdominal surgery and absence of contraindications for laparoscopic cholecystectomy.；

排除标准

Exclusion criteria included age under 16 years, pregnancy, diagnostic ERCP, Perforated gallbladder, suspected or confirmed malignancy and uncompleted ERCP. Patients not meeting the eligibility criteria were excluded. ERCP and LC procedures were performed by the same endoscopic surgeon. The indication for ERCP was thoroughly evaluated for each patient in consultation with a radiologist prior to the procedure.；

研究者信息
研究负责人姓名
试验机构

No financial support in this study

研究负责人电话
研究负责人邮箱
研究负责人邮编

46040

联系人通讯地址

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