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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 5
- 主要终点
- rate of postoperative bile leakage
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Patients, care providers and outcome assessors are blinded, the surgical team is not blinded.
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
- •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
排除标准
- •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
研究组 & 干预措施
Experimental Intervention (treatment)
Open bile ducts are identified by visual control of the liver resection surface combined with the direct injection in the cystic stump of 20-40ml of SMOFlipid 20% Fresenius Kabi Canada Ltd.; authorization number: 57231 (Swissmedic).
SMOFlipid is a white oily emulsion containing soya oil and medium chain triglycerides as main active components, normally used as parenteral nutrition as complement for essential fat acids supplementation. In this study the "white" test (= the administration of SMOFlipid retrograde through the cystic duct) is made by injection of one or two 20cc syringes full of lipidic solution (SMOFlipid 20%) in the cystic stump, directing the flow to the intrahepatic ducts. Residual fat emulsion is washed out from the biliary tract by a low pressure infusion of 20 to 50 ml of saline solution.
干预措施: "white" test" (= the administration of SMOFlipid retrograde through the cystic duct) (Drug)
结局指标
主要结局
rate of postoperative bile leakage
时间窗: within 30 days postoperative
Comparison of the rate of postoperative bile leakage in the control and in the intervention group. This is a binary endpoint defined by the presence or absence of the bile leakage (yes or no). Bile leakage is defined as bilirubin concentration in the drain fluid at least 3 times the serum bilirubin concentration on or after postoperative day 3.
次要结局
- Percutaneous Transhepatic Cholangio Drainage (PTCD) (yes/no)(within 30 days postoperative)
- Endoscopic retrograde cholangio pancreatography (ERCP) (yes/no)(within 30 days postoperative)
- Re-operation (yes/no)(within 30 days postoperative)
- Total hospital stay (in days)(within 30 days postoperative)
- In-Hospital morbidity other than related to the bile leakage(within 30 days postoperative)
- Severity of the bile leakage (Grade A, B or C according to the definition by Koch et al).(within 30 days postoperative)
- In-hospital mortality other than related to the bile leakage(within 30 days postoperative)
- Interventional drainage (yes/no)(within 30 days postoperative)
- Intensive care unit (ICU) stay (in days)(within 30 days postoperative)
研究者
Giulia Manzini
Dr. med., Senior physician, Department of Visceral Surgery
Kantonsspital Aarau