Interest of Intravenous Cholangiography With Indocyanine Green, Compared to Contrast Cholangiography, in the Context of Laparoscopic Cholecystectomy for Grade 1 and 2 Acute Gallstone Cholecystitis: Prospective, Monocentric, Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Change of surgical procedure after Indocyanine green injection
研究概览
简要总结
Acute lithiasis cholecystitis (ALC) is the third most common cause of surgical emergency admission. The initial treatment of ALC associates a medical support and a cholecystectomy, preferentially performed laparoscopically in the first 5 days of evolution. During the surgery, intraoperative cholangiography (CPO) using a contrast product is the "gold standard" to identify the bile ducts. However CPO is performed in approximately 30% of laparoscopic cholecystectomy.
Laparoscopic cholecystectomy for ALC is associated with an increase in the rate of biliary ducts injuries compared with cholecystectomy for symptomatic vesicular lithiasis, evaluated at 0.8 % versus 0.1 %. Its higher rate is related to local inflammation that alters the biliary anatomy and complicates the identification of the bile ducts. Indocyanine green facilitates the visualization of extrahepatic biliary structures, which could reduce the risk of biliary wound and shorten the operating time.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults patient (>18 years old)
- •Patients requiring laparoscopic cholecystectomy for grade 1 or 2 acute gallstone cholecystitis according to Tokyo recommendations confirmed by radiological morphological examination
- •Acute lithiasis cholecystitis (ALC) evolving for less than 5 days
- •Patients affiliated to a social security scheme
排除标准
- •Antecedent of biliary tract surgery
- •Antecedent of cholecystectomy
- •Contraindication to laparoscopy
- •Contraindication to surgery
- •Cholecystectomy by laparotomy out of hand
- •Grade 3 cholecystitis according to Tokyo recommendations
- •Acute alithiasis cholecystitis
- •Cirrhosis
- •Conversion for gangrenous ALC
- •Patient with an allergy to indocyanine green
- •Pregnant or lactating woman, childbearing age without effective contraception
- •Minor patient
- •Physical or psychological state that does not allow participation in the study, patient under guardianship or curatorship or patient deprived of liberty by a judicial or administrative decision (according with articles L 1121-6 and L 1121-8 of the French Public Health Code)
结局指标
主要结局
Change of surgical procedure after Indocyanine green injection
时间窗: day 0 = the day of the surgery
Change of surgical procedure after Indocyanine green injection compared to intraoperative cholangiography (CPO) using a contrast product as the "gold standard" to identify the bile ducts. Indocyanine green facilitates the visualization of extrahepatic biliary structures, which could reduce the risk of biliary wound and shorten the operating time.
次要结局
- Comparison of CPO (intraoperative cholangiography) achievement rates with visualized rates of the main bile duct via indocyanine green(day 0 = the day of the surgery)
- Comparison of biliary element recognition rate during laparoscopic cholecystectomy between CPO (intraoperative cholangiography) group and Indocyanine green injection (ICG) group after dissection(day 0 = the day of the surgery)
- Comparison of biliary element recognition rate during laparoscopic cholecystectomy between CPO (intraoperative cholangiography) group and Indocyanine green injection (ICG) group before dissection(day 0 = the day of the surgery)