Intravenous Injection Versus Transhepatic Intracholecystic Injection of Indocyanine Green (ICG) to Outline Biliary Tree During Laparoscopic Cholecystectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The rate of better delineation of the biliary tree during laparoscopic cholecystectomy
研究概览
简要总结
The current study shows that Indocyanine green (ICG)-fluorescence cholangiography can be useful in identifying the extrahepatic biliary anatomy during Calot's triangle dissection. By avoiding hepatic fluorescence, the transhepatic intracholecystic-ICG route can increase the bile duct-to-liver contrast with less expense and no risk of hypersensitivity reactions than the intravenous ICG injection method. We recommend to use both techniques in case of acute cholecystitis with cystic duct obstruction. In cases of liver cirrhosis, we recommend transhepatic IC-ICG as IV-ICG is limited.
详细描述
Materials and Methods After informed consent, 60 patients with acute or chronic cholecystitis scheduled for NIR-ICG fluorescent cholangiography during LC were consecutively included in the study. ICG was ad ministered intravenously or intracholecystic injection during surgery. This prospective randomized comparative was evaluated based mainly on the clear anatomical delineation of the gall bladder, cystic duct, hepatic ducts and common bile duct. This study had been conducted from 2022 to 2024 with the approval of the institutional ethics committee.
Inclusion criteria included patients from 16 to 80 years old, patients with gall bladder pathology (cholecystitis, gall bladder polyp) and patients fit for laparoscopic cholecystectomy.
Exclusion criteria included patients with contraindication for laparoscopic cholecystectomy (for example patients had significant pulmonary or cardiac problems or severe renal insufficiency), intraoperative dye spillage during dissection of the gallbladder, obstructive jaundice, proven or suspected allergies to ICG, pregnancy or lactation.
The patients were classified into 2 groups, group A patients (n = 30) were chosen for intravenous injection of ICG while group B patients (n = 30) were chosen for transhepatic intracholecystic injection of ICG during cholecystectomy.
To randomise, a sealed opaque envelope was chosen based on a computer-generated random sequence. Surgeons with extensive experience in biliary surgery performed all laparoscopic procedures. The patients age, sex, BMI, comorbidities, and cholecystectomy indication were among their characteristics. Perioperative data included the percentage of non-elective versus elective procedures, the length of time from skin incision to skin closure during the procedure, the location of intraoperative drains, the estimated blood loss (EBL), and the necessity of switching from a laparoscopic to an open approach.
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
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of gall bladder pathology (cholecystitis, gall bladder polyp) Patients fit for laparoscopic cholecystectomy.
排除标准
- •Patients with contraindication for laparoscopic cholecystectomy (for example patients had significant pulmonary or cardiac problems or severe renal insufficiency).
- •Proven or suspected allergies to ICG. pregnancy or lactation.
研究组 & 干预措施
Intravenous Injection Injection of Indocyanine Green (ICG)
7.5 mg (3 ml of a 25 mg/10 ml solution) of indocyanine green was injected intravenously in the pre-operative holding area at least 20 minutes before surgery to outline the biliary tree during laparoscopic cholecystectomy.
干预措施: Indocyanine Green (Drug)
Transhepatic intracholecystic injection of Indocyanine Green (ICG)
Intracholecystic injection of ICG was done in 30 patients. Twenty 1.25 mg particles, one from a 25 mg ICG vial, were separated under aseptic conditions.
干预措施: Indocyanine Green Drug (Drug)
结局指标
主要结局
The rate of better delineation of the biliary tree during laparoscopic cholecystectomy
时间窗: intraoperative and 2 weeks postoperative
To detect the safety, efficacy, feasibility and accuracy in defining the biliary anatomy during laparoscopic cholecystectomy.
次要结局
未报告次要终点
研究者
Mahmoud Rady
Researcher
Theodor Bilharz Research Institute