Safety and Feasibility of Modified Laparoscopic Transcystic Biliary Drainage in the Management of Cholecystocholedocholithiasis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- postoperative overall morbidity
研究概览
简要总结
The modified laparoscopic transcystic biliary drainage which we developed in the treatment of cholecystocholedocholithiasis has some advantages over conventional techniques.
Here, a 7-Fr triple-lumen 30-cm central venous catheter was adopted to replace conventional 5-Fr ureteral catheter, which extended the function of the C-tube.
Then we developed a continued suture and circling manner by the V-Loc closure device, which simultaneously covered and anchored the C-tube.
Theoretically, this modified laparoscopic transcystic drainage not only provide safe and effective bile duct drainage, but also provide a convenient access of treatment for postoperatively retained bile duct stones, which may expand the indication of initially laparoscopic operation in the management of cholecysto-choledocholithiasis.
详细描述
The modified laparoscopic transcystic biliary drainage which we developed in the treatment of cholecystocholedocholithiasis has some advantages over conventional techniques.
Here, a 7-Fr triple-lumen 30-cm central venous catheter was adopted (Arrow International Inc., Pennsylvania, U.S.A.) to replace conventional 5-Fr ureteral catheter, which extended the function of the C-tube.
Then we developed a continued suture and circling manner by the V-Loc closure device (Covidien V-Loc 180 3-0®, Mansfield, MA, US), which simultaneously covered and anchored the C-tube.
Furthermore, the catheter was introduced through the abdominal wall located at 3 cm below the costal margin on the midaxillary line/the posterior axillary line, which was traditionally performed at the point below the midclavicular line on the right side. Our modified path could avoid the compression of the C-tube by hepatic margin and hence decrease the dislocation of the C-tube. In addition, the retroperitoneal path may increase adherence development and sinus-tract formation.
More importantly, this path could easily be available when the patient be placed in the prone position for ERCP, which can conveniently facilitate the guidewire passed through the C-tube down to the duodenum to perform postoperative rendezvous technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years of age;
- •Patients with gallbladder stones and known or expected concomitant bile duct stones;
- •Informed consent.
排除标准
- •Biliary drainage is already present, e.g. preoperative ENBD, PTCD;
- •Women who are pregnant;
- •Declined consent;
- •Inability to follow the procedures of the study, e.g. due to language problems and psychological disorders of the participant;
- •Morbid obesity (BMI > 40);
- •IV-VI class of the American Society of Anesthesiologists physical status classification;
- •Contraindications for general anesthesia or surgery.
结局指标
主要结局
postoperative overall morbidity
时间窗: 6 months
All outcome variables will be assessed according to internationally accepted standards if available, that is, the consensus definitions for surgical and medical complications according to the Clavien-Dindo classification.
bile leakage
时间窗: 6 months
Bile leakage is determined according to the definition and grading of severity by the International Study Group of Liver Surgery.
次要结局
- anchoring time of the C-tube(6 months)
- average daily drainage volume(6 months)
- early dislodgement of C-tube(6 months)