Indocyanine Green Fluorescence During Fundus First Laparoscopic Cholecystectomy

Обзор

Laparoscopic cholecystectomy is the routine method for managing gallstone disease. This is considered a safe procedure with low risk of severe complications. Lesions to the deep bile ducts is, however, a rare complication from laparoscopic cholecystectomy that may have devastating consequences. The risk of bile duct injuries may be reduced by adapting the surgical approach. In general, the operation is started from the lower part of the gallbladder and continued upwards. It may, however, also be initiated from the top of the gallbladder and extended downwards. This approach, also termed fundus first, is routine at a few units. By injecting Indocyanin Green (ICG) that is excreted into the bile, the bile ducts may be visualized using near infrared light. This is a technique for mapping the anatomical structures adjacent to the gallbladder that has been used in previous studies for preventing bile duct injuries. This method has, however, not been tested at units where fundus first is the routine surgical technique. In the present randomized controlled trial, the investigators intend to evaluate the safety of ICG as a means for reducing the risk of bile duct lesions and to see if it works as intended. Altogether 294 operations for gallstones will be included in the study. The patients will be randomized to surgery with or without ICG. Regardless of the randomization, all operations will be undertaken with the fundus first technique. Thirty days after the operation, all data related to the operation are retrieved from the patient records by an assessor that does not know what group the patient was randomized to. The primary endpoint of the study is the time required from the start of the operation until intraoperative cholangiography is done. In addition, total operative time, all surgical complications and need for converting the operation to an open procedure will be recorded.

Вмешательства

• Процедура Indocyanine Green
  Visualization of the bile ducts with ICG
• Процедура Cholangiography
  Visualization of the bile ducts with intraoperative cholangiography

Первичные конечные точки

• Time to intraoperative cholangiography [Срок оценки: During procedure.]

Вторичные конечные точки (6)

• Procedure-related complications [Срок оценки: Up to 30 days postoperatively]
• Total operative time [Срок оценки: During procedure]
• Intraoperative gallbladder perforation [Срок оценки: During procedure]
• Conversion from laparoscopic to open cholecystectomy [Срок оценки: During procedure]
• Surgeon perception of complexity [Срок оценки: During procedure]
• Patient reported outcome [Срок оценки: Up to 30 days postoperatively]

Критерии участия

Критерии включения

• Patients undergoing laparoscopic cholecystectomy
• Verbal and written consent provided
• Age ≥ 18 years

Критерии исключения

• Thyroid disease
• Allergy against ICG or Iodine

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06918210 · INFUNDUS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗