Role of Indocyanine Green in Visualizing Critical View of Safety During Laparoscopic Cholecystectomy for Acute Cholecystitis
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Percentage of surgeries in which Critical View of Safety was achieved
研究概览
简要总结
The purpose of this prospective randomized trial is to study the role of Indocyanine green (ICG) to visualize the Critical View of Safety during emergency Laparoscopic Cholecystectomy for patients with Acute Cholecystitis.
详细描述
After informing about the study and obtaining consent to participate, patients who are diagnosed with Acute Cholecystitis and posted for emergency Laparoscopic Cholecystectomy will be randomly assigned to receive either ICG or not as a method to identify the Critical View of Safety during the operation.
The primary outcome is whether there was a precise and satisfactory visualization of the junction between the cystic duct, the common hepatic duct, and the common bile duct by indocyanine green compared to the control group. The time taken to achieve this will be measured in minutes from video recordings of the laparoscopic surgery. The process will be further assessed by a surgeons' satisfaction score.
The expected duration of the study will be 12 months involving a total of 80 patients randomized into two groups- 40 patients in the intervention group and 40 patients in the control group.
The expected outcome of the study is that ICG is more effective than the control group in providing precise and satisfactory visualization of Critical View of Safety and takes less time. We predict the surgeons to be equally or more satisfied with ICG compared to control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The patient is blinded to the intervention S/he receives. The surgeon, investigator, and outcomes assessor are masked but not strictly blinded up to the point when the near-infrared camera is switched on
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 emergency Laparoscopic Cholecystectomy for Acute Cholecystitis
- •Patient age ≥ 18 years.
- •Patients who consent to take part in the study
排除标准
- •Preoperative planned for Open Cholecystectomy
- •Allergy towards iodine, iohexol or ICG
- •Pregnancy or lactation
- •Renal insufficiency
- •Legally incompetent for any reason
- •Withdrawal of inclusion consent at any time
- •Prisoners
研究组 & 干预措施
ICG group
Participants receive an intravenous injection of 0.05 mg/kg of ICG 45 minutes preoperatively.
A Pinpoint Endoscopic Fluorescence System (Novadac Technologies Inc., Canada) for ICG Fluorescence Observation with the easy switchable white light-fluorescent mode is used.
Before dividing any tubular structure, the fluorescence imaging mode is routinely used again, and fluorescent angiography is performed by re-injecting the same dose of ICG as initially used.
After the division of the cystic duct and artery, the fluorescence imaging mode is applied again to check for bile leakage.
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
Percentage of surgeries in which Critical View of Safety was achieved
时间窗: Prior to clipping of the Cystic Duct and Cystic Artery or decision to perform conventional intraoperative cholangiography or convert to open.
Percentage of surgeries where there was complete visualization of Critical View of Safety by intraoperative fluorescent cholangiography compared to the control group with no fluorescent imaging. Complete visualization of the Critical View of Safety is defined by the SAGS guidelines. The laparoscopic procedure is recorded \& assessed individually \& separately by two consultant surgeons who are not the operating surgeon whether the Critical View of Safety was achieved prior to clipping of Cystic Duct \& Cystic Artery. Failure of identification of Critical View of Safety is defined as the need for further conventional intraoperative cholangiography or open conversion due to inability to accurately identify the biliary anatomy to complete the cholecystectomy safely.
次要结局
- Time taken to identify Critical View of Safety(After securing working ports till Clipping of Cystic Duct or Artery.)
- Surgeon's Satisfaction Survey(Prior to clipping of the Cystic Duct and Cystic Artery or decision to perform conventional intraoperative cholangiography or convert to open.)
研究者
Dr Zia Ahmed Aftab, MBBS,FRCS,FACS
Consultant in Acute Care Surgery
Hamad Medical Corporation