Two Institutes Experience In Laparo-Endoscopic Rendezvous Technique For Patients Undergoing Laparscopic Cholecystectomy For Stones In The Gallbladder And Bile Duct; A Prospective Randomized Comparative Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 432
- 主要终点
- successful stone clearance from the CBD
研究概览
简要总结
The management of gallbladder stones (lithiasis) concomitant with bile duct stones is controversial. The management of CBD stones has evolved considerably since the advent of laparoscopic surgery. The more frequent approach is a two-stage procedure, with endoscopic sphincterotomy and stone removal from the bile duct followed by laparoscopic cholecystectomy. The laparoscopic-endoscopic rendezvous combines the two techniques in a single-stage operation. So the aim of this study was was to evaluate one-stage LC with intra-operative endoscopic sphincterotomy (IOES) vs two-stage pre-operative endoscopic sphincterotomy (POES) followed by LC for the treatment of cholecystocholedocholithiasis.
详细描述
This is two center study was carried out on 523 patients and completed in 436 patients with gall bladder stones and with suspected or confirmed CBDS at two gastroenterology center at zagazig first 264 patients at the Gastrointestinal Surgery Unit in the Zagazig University Hospitals and second 172 patients at gastroenterology unite at AL AHRAR hospital from January 2010 till April 2022. A single-step technique combining LC and IO-ERCP was used to treat them. To confirm the presence of CBDS, a laparoscopic intraoperative cholangiography (IOC) was performed. A soft-tipped guidewire was inserted into the duodenum through the cystic duct and papilla. Over the guide-wire, an endoscopic papillotomy was introduced. The stones were retrieved with a retrieval balloon after an IO-ERCP and endoscopic sphincterotomy. The length of the postoperative hospital stay, surgical operating time, surgical success rate, postoperative complications, and residual CBDS were all evaluated. 77 patients excluded either incomplete data or didn't complete both steps within our centers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
盲法说明
both the participant patients and the surgeon had no knowledge about the chosen procedure and the choosen procedure were known by the investigator who told the surhgeon later which procedure to perform for the selected patient.
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
- •patients having stone in the gallbladder and concurrent CBD stone, as determined by MRCP or US.
- •Patients with acute cholecystitis, acute cholangitis, obstructive jaundice, and those with highly suspicious criteria for CBD, stones such as dilated CBD on US examination more than7 mm in diameter without obvious CBD stones, high serum bilirubin level, and or high serum alkaline phosphatase level, were also included in this study.
排除标准
- •Patients with history of hepatobiliary surgery as choledocho-duodenal anastomosis.
- •Patients with previous ERCP attempt.
- •Patients with previous upper abdominal surgery as total or partial gastric resection.
- •Patients with morbid obesity.
- •Patients with uncorrectable coagulopathy.
- •Patients aged below 18 years or above 80 years.
- •Patients within the American Society of Anesthesiology (ASA) class 4 and 5 disease.
- •Patients who refused to give consent or participate in the study.
结局指标
主要结局
successful stone clearance from the CBD
时间窗: first year postoperatively
To ensure that the bile duct was completely clear, a check cholangiogram was conducted.
次要结局
未报告次要终点
研究者
Mohamed I Farid
assistant professor
Zagazig University