Randomized Clinical Trial for the Optimization of Indocyanine Green Administration in Near-infrared Fluorescent Cholangiography During Laparoscopic Cholecystectomy.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.
研究概览
简要总结
Laparoscopic cholecystectomy is one of the most performed surgical procedures worldwide. One of its most serious complications is injury to the main bile duct, with an incidence of less than 1%. There are different surgical strategies that try to reduce this complication, with indocyanine green fluorescence cholangiography being one of the most recent to appear. This technique is becoming a great tool during laparoscopic cholecystectomy. Despite the great rise of the procedure, today there is a great disparity in the administration protocols of indocyanine green during the procedure.
Goals. The main objective of the study is to analyze whether there are differences between different types of doses and administration intervals of indocyanine green to obtain quality fluorescent cholangiography during laparoscopic cholecystectomy. In addition, the factors that influence the results of the technique will be sought.
详细描述
Symptomatic cholelithiasis is a pathology of great relevance in the world population, with prevalence rates of up to 20%. The standard treatment for cholelithiasis is laparoscopic cholecystectomy (LC). One of the most serious complications of LC is injury to the main bile duct (LVB). Although this complication has incidences of less than 1% (0.3-0.7% in the different series), the consequences it causes are highly relevant. LVB is related to a significant increase in patient morbidity and mortality, a significant deterioration in quality of life, a very significant increase in healthcare costs and not insignificant medical-legal consequences. Indocyanine green fluorescence cholangiography (CF-VI) is a novel technique that allows precise and real-time anatomical visualization of the extrahepatic biliary anatomy, facilitating surgery and reducing the risk of complications. Currently, there are large differences in LV administration protocols during CF in LC. The precise dose and the ideal moment of administration are key to achieving adequate visualization of the critical vascular and biliary structures and to reduce the fluorescence emitted by the hepatic parenchyma, which could hinder correct anatomical visualization. In relation to the dose, there are many protocols for IV administration, by means of a single dose or a dose adjusted for the patient's body weight. Some authors advocate the administration of IV 24 hours before the procedure, in order to avoid hepatic fluorescence. However, in the context of major outpatient surgery, outpatient surgery or short-stay surgery, we believe that this practice is not currently logistically feasible. Other groups administer the IV with a variable range of time interval. The recent preliminary results of the European Registry of Fluorescent Image Guided Surgery show the great disparity of preoperative LV administration protocols. Therefore, it is necessary to protocolize the administration of the drug based on the results of randomized clinical trials.. The precise dose and the ideal moment of administration are key to achieving adequate visualization of the critical vascular and biliary structures and to reduce the fluorescence emitted by the hepatic parenchyma, which could hinder correct anatomical visualization.
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
- •Age over 18 years.
- •Autonomy, self-sufficiency and independence.
- •Scheduled CL indication:
- •Symptomatic cholelithiasis: history of biliary colic, acute lithiasic cholecystitis, choledocholithiasis, acute ascending cholangitis of lithiasic origin or acute lithiasic pancreatitis.
- •Gallbladder polyps with indication for laparoscopic surgery.
- •Vesicular adenomyomatosis with indication for laparoscopic surgery.
- •Indication of early LC (<72 hours of admission for acute stone cholecystitis/acute acalculous cholecystitis/complicated biliary colic).
- •Deferred urgency LC indication.
- •Understanding of information.
- •Signature of the informed consent.
排除标准
- •Age less than 18 years.
- •Disability.
- •Pregnancy or lactation.
- •Chronic kidney disease (Stage > IIIb).
- •Previous adverse reactions or allergies to VI.
- •Previous adverse reactions or allergies to VI excipients.
- •Adverse reactions or confirmed allergies to iodinated contrast agents.
- •Functional thyroid pathology (hyperthyroidism, thyroiditis, toxic multinodular goiter, functioning thyroid adenoma).
- •Urgent non-deferrable/emergent gallbladder surgery.
- •Initial surgery by laparotomy.
- •Previous suspicion of gallbladder carcinoma.
- •Inability to understand the information needed to participate in the study.
- •Rejection of inclusion within the study protocol.
研究组 & 干预措施
Fixed dose 3 hours
Fixed dose 2.5 mg with IV administration at a time greater than 3 hours before surgery.
干预措施: VERDYE powder for solution for injection 25 mg (Drug)
Fixed dose 30 min
Fixed dose 2.5 mg with IV administration during the immediate preoperative period (15-30 minutes before surgery).
干预措施: VERDYE powder for solution for injection 25 mg (Drug)
Weight-adjusted dose 3 hour
Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration greater than 3 hours before surgery.
干预措施: VERDYE powder for solution for injection 25 mg (Drug)
Weight-adjusted dose 30 min
Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration during the immediate preoperative period (15-30 minutes before surgery).
干预措施: VERDYE powder for solution for injection 25 mg (Drug)
结局指标
主要结局
Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.
时间窗: During surgical procedure, before beginning the dissection of the hepatocystic triangle.
Identification of biliary structures prior to dissection of the hepatocystic triangle. Participants may be assigned to multiple categories according to the intraoperative identification of distinct anatomical structures observed in each case. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the surgery has begun, but before the disection of the hepatocystic triangle has begun. Category 1. Identification of the cystic duct prior to dissection Category 2. Identification of the common bile duct prior to dissection Category 3. Identification of the junction of the cystic duct with the common bile duct prior to dissection Category 4. Identification of the union of the cystic duct with the gallbladder prior to dissection Category 5. Identification of the common hepatic duct prior to dissection Category 6. Identification of biliary anatomical variables prior to dissection
Identification of Biliary Structures After Dissection of the Hepatocystic Triangle.
时间窗: During surgical procedure, after dissection of the hepatocystic triangle.
Identification of biliary structures after dissection of the hepatocystic triangle. Participants may be assigned to multiple categories according to the intraoperative identification of distinct anatomical structures observed in each case. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once disection of the hepatocystic triangle has begun. Category 1. Identification of the cystic duct prior to dissection Category 2. Identification of the common bile duct prior to dissection Category 3. Identification of the junction of the cystic duct with the common bile duct prior to dissection Category 4. Identification of the union of the cystic duct with the gallbladder prior to dissection Category 5. Identification of the common hepatic duct prior to dissection Category 6. Identification of biliary anatomical variables prior to dissection
次要结局
- Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.(During surgical procedure, before beginning the dissection of the hepatocystic triangle.)
- Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle.(During surgical procedure, after the disection of the hepatocystic triangle has begun.)
- Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery(During surgical procedure)
- Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing.(During surgical procedure)