Fluorescence Cholangiography Versus X-ray Cholangiography During Laparoscopic Cholecystectomy for Complicated Gallstone Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Visualization of the cystic duct - common hepatic duct - common bile duct junction
研究概览
简要总结
The primary objective is to compare the success rates of intraoperative fluorescent cholangiography using indocyanine green versus conventional X-ray cholangiography for the identification of bile duct anatomy during laparoscopic cholecystectomy for complicated gallstone disease in a randomized design with 120 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient scheduled for planned laparoscopic cholecystectomy by one surgeon
- •Complicated gallstone disease
排除标准
- •Open cholecystectomy
- •Allergy towards iodine, urografin or indocyanine green
- •Liver or renal insufficiency
- •Thyrotoxicosis
- •Pregnancy or lactation
- •Legally incompetent for any reason
- •Withdrawal of inclusion consent at any time
研究组 & 干预措施
Fluorescence cholangiography
After induction of anaesthesia 2.5-7.5 mg of indocyanine green (0.05 mg/kg) is injected intravenously. The operation field is routinely inspected in the fluorescence imaging mode before dissection of Calot´s triangle. During dissection, the fluorescence imaging mode is used when needed, before division of any tubular structure and after division of the cystic duct and artery.
干预措施: Indocyanine green (Drug)
Fluorescence cholangiography
After induction of anaesthesia 2.5-7.5 mg of indocyanine green (0.05 mg/kg) is injected intravenously. The operation field is routinely inspected in the fluorescence imaging mode before dissection of Calot´s triangle. During dissection, the fluorescence imaging mode is used when needed, before division of any tubular structure and after division of the cystic duct and artery.
干预措施: Near-infrared illumination (Device)
X-ray cholangiography
The cholangiography is performed after dissection of the cystic duct by cannulation of the cystic duct with a catheter using either a Kumar- or Olsen grasper. A mobile X-ray C-arm system is used, and the monochrome X-ray image is shown on a separate screen. After satisfactory identification of the extra-hepatic biliary ducts, the intraoperative cholangiography is discontinued and the gallbladder is removed in a standardized manner.
干预措施: Urografin (Drug)
X-ray cholangiography
The cholangiography is performed after dissection of the cystic duct by cannulation of the cystic duct with a catheter using either a Kumar- or Olsen grasper. A mobile X-ray C-arm system is used, and the monochrome X-ray image is shown on a separate screen. After satisfactory identification of the extra-hepatic biliary ducts, the intraoperative cholangiography is discontinued and the gallbladder is removed in a standardized manner.
干预措施: X-ray (Radiation)
结局指标
主要结局
Visualization of the cystic duct - common hepatic duct - common bile duct junction
时间窗: Intraoperative
次要结局
- Surgeon satisfaction score (Measured on a 5 point VAS scale)(Intraoperative)
- Per-/postoperative adverse events as a measure of safety and tolerability(Intraoperative)
- Time spend for intraoperative fluorescent cholangiography/conventional X-ray cholangiography(Intraoperative)
- Total cost of operation incl fluorescent/conventional X-ray cholangiography(Admission to discharge from hospital (0-30 days))
研究者
Lars Lang Lehrskov
MD
Hvidovre University Hospital