Comparison Between Standard and Reduced Doses of Indocyanine Green in Fluorescence Cholangiography During Laparoscopic Cholecystectomy.

Официальное название

Reduced Dose vs Standard Dose of Indocyanine Green in Near-infrared Fluorescence Cholangiography During Laparoscopic Cholecystectomy: a Randomized Clinical Trial.

Обзор

Introduction: This protocol outlines a randomized phase IV clinical trial designed to compare the efficacy of two different doses of indocyanine green (ICG) used in near-infrared fluorescent cholangiography during laparoscopic cholecystectomy (LC)-the current gold standard treatment for symptomatic cholelithiasis. Despite its effectiveness, LC is still associated with significant risks, particularly bile duct injury (BDI), a severe complication that this study aims to mitigate. Phase: Phase IV Study design: Multicenter, randomized, open-label, parallel-group clinical trial (modified intention-to-treat). Objectives: Primary objective: * To analyze differences between treatment groups (standard dose 2.5 mg \>3h preoperative vs reduced dose 0.25 mg immediate preoperative 15-30 min) during laparoscopic cholecystectomy in: * Visualization of extrahepatic biliary structures * Degree of visualization * Degree of background liver fluorescence interference * Perceived utility of the technique Secondary objectives: * Influence of BMI, biliary pathology type, surgery type, prior inflammation, surgical difficulty, previous instrumentation, and laparoscopic imaging system on results * Intraoperative and postoperative complication rates * 30-day mortality * Impact on operative time and hospital stay * Correlation between subjective and objective fluorescence assessment (ducts-to-liver fluorescence ratio) Population: Patients ≥18 years indicated for laparoscopic cholecystectomy (elective, early or urgent deferred). Main inclusion criteria: * Age ≥18 years * Signed informed consent * Indication for laparoscopic cholecystectomy (symptomatic cholelithiasis, gallbladder polyps with surgical indication) Main exclusion criteria: * Age \<18 years * Pregnancy or lactation * Chronic kidney disease (stage \>IIIb) * ICG or iodinated contrast allergy * Functional thyroid disease * Emergency non-deferrable surgery * Open approach * Suspicion of gallbladder carcinoma * Inability to understand the study Investigational product: Indocyanine green (ICG), intravenous administration This multicenter study involves two hospitals in Castilla y León, Spain, and plans to enroll 122 adult patients meeting specific clinical criteria for LC. Participants will be randomized into two treatment arms and will receive ICG accordingly: * Group 1: 2.5 mg \>3h before surgery * Group 2: 0.25 mg 15-30 min before surgery Fluorescence will be assessed both subjectively by the surgical team and objectively through digital image analysis using specialized software to calculate the bile duct-to-liver fluorescence ratio (RFBH). Endpoints: * Rates and degree of biliary structure identification pre- and post-dissection * Perceived utility of cholangiography * Liver background fluorescence interference * Ducts-to-liver fluorescence ratio Duration: 12 months recruitment + 1 month follow-up = total 13 months Countries: Spain Ethics: The study will be conducted in accordance with ICH-GCP, EU Clinical Trials Regulation No 536/2014, and applicable national regulations. Beyond comparing the diagnostic performance of two dosing strategies, this study seeks to provide evidence supporting a more practical and logistically feasible approach for implementing ICG fluorescence cholangiography in routine surgical practice, without compromising diagnostic accuracy or patient safety.

Вмешательства

• Препарат Intravenous injection of indocianine green at least three hours before surgery at a dose of 2.5 mg per subject.
  A dilution will be prepared by dissolving 25 mg of ICG in 10 mL of water for injectable solutions, yielding a concentration of 2.5 mg/mL. Once the solution is prepared, 1 mL will be administered directly via a peripheral venous line in the patient's upper limb.
• Препарат Intravenous injection of indocianine green 15 to 30 minutes before surgery at a dose of 0.25 mg per subject.
  A dilution will be prepared by dissolving 25 mg of ICG in 25 mL of water for injectable solutions, yielding a concentration of 1 mg/mL. Subsequently, 0.25 mL will be administered as a direct intravenous injection via a peripheral venous line in the patient's upper limb.

Первичные конечные точки

• Identification of biliary structures prior to dissection of the hepatocystic triangle. [Срок оценки: During surgery]
• Identification rate of biliary structures after dissection of the hepatocystic triangle [Срок оценки: During surgery.]
• Degree of identification of extrahepatic biliary structures prior to dissection of the hepatocystic triangle [Срок оценки: During surgery]
• Degree of identification of extrahepatic biliary structures after dissection of the hepatocystic triangle [Срок оценки: During surgery.]
• Perceived usefulness of fluorescence cholangiography (FC). [Срок оценки: During surgery]
• Degree to which background liver fluorescence (contrast between the liver and biliary ducts) was perceived as disturbing [Срок оценки: During surgery]

Вторичные конечные точки (4)

• To analyze the rate of postoperative complications related to FC during LC. [Срок оценки: From surgery to 30 days post-surgery]
• To analyze hospital and 30-day mortality rates. [Срок оценки: From surgery to 30 days post-surgery]
• To analyze the impact of the technique on operative time, intraoperative/postoperative complications, and hospital stay. [Срок оценки: From surgery to 30 days post-surgery.]
• To analyze the correlation between the subjective and objective assessment of the procedure through the use of the bile duct-to-liver fluorescence ratio. [Срок оценки: During surgery.]

Критерии участия

Критерии включения

• Age ≥18 years.
• Signed informed consent.
• Indication for laparoscopic cholecystectomy (symptomatic cholelithiasis or gallbladder polyps).

Критерии исключения

• Age <18 years.
• Pregnancy or lactation.
• Chronic kidney disease (stage >IIIb).
• ICG allergy.
• Allergy to other iodinated contrast
• Functional thyroid disease.
• Emergency non-deferrable surgery.
• Open approach.
• Suspicion of gallbladder cancer.
• Inability to understand the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 2 центра

• Hospital Universitario de Salamanca — Salamanca
• Hospital Virgen de la Concha — Zamora

Идентификаторы

NCT: NCT07195331 · Low-DOTIG · 2025-522535-33-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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