LOW DOse vs standard dose and administration TIme in near-infrared fluorescence cholangiography during laparoscopic cholecystectomy: a randomised clinical trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Rate of identification of biliary structures prior to dissection of the hepatocystic triangle.
研究概览
简要总结
To analyze the differences between treatment groups [standard dose of 2.5 mg administered >3 hours preoperatively vs. reduced dose (0.25 mg) administered immediately preoperatively (15 minutes)], during laparoscopic cholecystectomy (LC), in terms of:
Visualization of extrahepatic biliary structures. Degree of visualization of these structures. Degree of background hepatic fluorescence disturbance. Perceived utility of the technique across treatment groups.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Adult patient (≥18 years old) who is able to understand and sign the informed consent form.
- •Indication for: a) Elective laparoscopic cholecystectomy (LC) due to: Symptomatic cholelithiasis (history of biliary colic, acute calculous cholecystitis, choledocholithiasis, ascending acute lithiasic cholangitis, or acute biliary pancreatitis); Gallbladder polyps with indication for laparoscopic surgery. b) Early LC indication (<72 hours from hospital admission) for: Acute calculous cholecystitis; Acute acalculous cholecystitis; Complicated biliary colic. c) Indication for delayed emergency LC.
排除标准
- •Patient under 18 years of age.
- •Inability to understand the information required to participate in the study or to complete follow-up.
- •Pregnancy or breastfeeding.
- •Chronic kidney disease (Stage > IIIb).
- •History of adverse reactions or allergies to indocyanine green (ICG).
- •Confirmed adverse reactions or allergies to iodinated contrast agents.
- •Functional thyroid disorders (e.g., hyperthyroidism, thyroiditis, toxic multinodular goiter, functioning thyroid adenoma).
- •Non-deferrable/emergency gallbladder surgery.
- •Primary open (laparotomic) cholecystectomy.
- •Preoperative suspicion of gallbladder carcinoma.
结局指标
主要结局
Rate of identification of biliary structures prior to dissection of the hepatocystic triangle.
Rate of identification of biliary structures prior to dissection of the hepatocystic triangle.
Rate of identification of biliary structures after dissection of the hepatocystic triangle.
Rate of identification of biliary structures after dissection of the hepatocystic triangle.
Degree of identification of extrahepatic biliary structures prior to dissection of the hepatocystic triangle (1 = poor, 2 = good, 3 = excellent).
Degree of identification of extrahepatic biliary structures prior to dissection of the hepatocystic triangle (1 = poor, 2 = good, 3 = excellent).
Degree of identification of extrahepatic biliary structures after dissection of the hepatocystic triangle (1 = poor, 2 = good, 3 = excellent).
Degree of identification of extrahepatic biliary structures after dissection of the hepatocystic triangle (1 = poor, 2 = good, 3 = excellent).
Perceived usefulness of fluorescence cholangiography during surgery (1 = not useful, 2 = moderately useful, 3 = very useful).
Perceived usefulness of fluorescence cholangiography during surgery (1 = not useful, 2 = moderately useful, 3 = very useful).
Perceived disturbance from background liver fluorescence (liver-to-duct contrast): 0 = none, 1 = slight, 2 = significant.
Perceived disturbance from background liver fluorescence (liver-to-duct contrast): 0 = none, 1 = slight, 2 = significant.
次要结局
- Analysis on the primary variables described above, corresponding to the predictors of the technique: sex, BMI, type of biliary pathology, type of surgery, previous inflammatory changes, degree of surgical difficulty, previous instrumentation and imaging systems.
- Analysis of intraoperative and postoperative complication rates of the technique, categorised by treatment group.
- Analysis of the relationship between surgical time and length of hospital stay.
研究者
Esperanza Lopez Franco
Scientific
Fundacion Instituto De Estudios De Ciencias De La Salud De Castilla Y Leon