Diagnostic Role of the "White Test" With Lipidic Solution in the Early Intraoperative Identification of Open Bile Ducts for the Prevention of Bile Leakage After Liver Resection (BiLe -Trial)

Официальное название

Diagnostic Role of the "White Test" With Lipidic Solution in the Early Intraoperative Identification of Open Bile Ducts for the Prevention of Bile Leakage After Liver Resection- A Randomized Controlled Multicentric Superiority Trial- The BiLe-Trial (Bile Leakage Trial)

Обзор

Bile leakage (BL) is the most frequent complication after liver resection. This study is to investigate the role of intraoperative administration of SMOFlipid 20% (fat emulsion which allows intraoperative identification of open bile ducts at the liver resection surface when it is administered retrograde through the cystic duct) in terms of prevention of postoperative BL within 30 days after surgery.

Подробное описание

Bile leakage (BL) is the most frequent complication after liver resection leading to the need of interventional drainage, endoscopic retrograde cholangio pancreatography (ERCP) or even reoperation. Strategies leading to a reduction of the rate of this complication are valuable. SMOFlipid 20% is a fat emulsion which is primary indicated for parenteral nutrition. Because of its fatty content this solution is white. This allows the clear intraoperative identification of open bile ducts at the liver resection surface when it is administered retrograde through the cystic duct. Consequently, open bile ducts can be sutured preventing the postoperative development of BL. If the rate of bile leakages can be reduced, resources for interventions and relaparotomy will be saved. This study is to investigate intraoperative administration of SMOFlipid 20% in terms of prevention of BL within 30 days after surgery.

Вмешательства

• Препарат "white" test" (= the administration of SMOFlipid retrograde through the cystic duct)
  "white" test" (= the administration of SMOFlipid retrograde through the cystic duct)

Первичные конечные точки

• rate of postoperative bile leakage [Срок оценки: within 30 days postoperative]

Вторичные конечные точки (9)

• Severity of the bile leakage (Grade A, B or C according to the definition by Koch et al). [Срок оценки: within 30 days postoperative]
• In-hospital mortality other than related to the bile leakage [Срок оценки: within 30 days postoperative]
• In-Hospital morbidity other than related to the bile leakage [Срок оценки: within 30 days postoperative]
• Endoscopic retrograde cholangio pancreatography (ERCP) (yes/no) [Срок оценки: within 30 days postoperative]
• Percutaneous Transhepatic Cholangio Drainage (PTCD) (yes/no) [Срок оценки: within 30 days postoperative]
• Interventional drainage (yes/no) [Срок оценки: within 30 days postoperative]
• Re-operation (yes/no) [Срок оценки: within 30 days postoperative]
• Intensive care unit (ICU) stay (in days) [Срок оценки: within 30 days postoperative]
• Total hospital stay (in days) [Срок оценки: within 30 days postoperative]

Критерии участия

Критерии включения

• Patients who will receive an anatomical resection of two or more liver segments for any reason with simultaneous cholecystectomy in elective Setting
• Patients who will receive an anatomical resection of two or more liver segments for any reason which already had a cholecystectomy if intraoperatively the cystic stump can be identified and opened
• Ability of subject to understand character and individual consequences of the clinical Trial
• Informed consent documented by signature

Критерии исключения

• Previous cholecystectomy if intraoperative it is not possible to identify the cystic stump
• Intraoperative hepatico-jejunostomy
• Hypersensitivity to fish-, egg-, soybean or peanut protein or to any of the active ingredients or excipients
• Immunosuppression, pregnancy
• Emergency liver resection because of traumatic liver rupture
• Enrolment of the investigator, his/her family members, employees and other dependent persons

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

Тройное слепое

Основная цель

Профилактика

Центры проведения

Швейцария · 5 центров

• Department of Visceral Surgery, Cantonal Hospital of Aarau — Aarau
• Clarunis Basel, Universitäres Bauchzentrum Basel — Basel
• Kantonsspital Luzern — Lucerne
• Ospedale Regionale di Lugano — Lugano
• Kantonsspital St. Gallen — Sankt Gallen

Публикации

• Cristaudi A, Tarantino I, Scheiwiller A, Wiencierz A, Majno-Hurst P, Schmied BM, Metzger J, Hartel M, Kremer M, Manzini G. Diagnostic role of the 'white test' with lipidic solution in the early intraoperative identification of open bile ducts for the prevention of bile leakage after liver resection: study protocol for a randomised controlled multicentric superiority trial (BiLe-Trial). BMJ Open. 2 PMID 34326053

Идентификаторы

NCT: NCT04523701 · 2020-02081; ex20Manzini

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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