Comparison of Hydro-dissection Versus Ultrasonic Aspirator in Division of Liver Parenchyma in Laparoscopic Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Intraoperative Blood Loss
研究概览
简要总结
Background: until now, there is no agreement about the safest and feasible method for liver parenchyma transection during laparoscopic liver resection.
Study design: prospective, randomized, single-center The purpose of the study: comparison of short-term results of two methods of parenchyma liver transection during laparoscopic liver resection
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with benign lesions (hemangioma, focal nodular hyperplasia [FNH], hepatocellular adenoma, biliary cystadenoma, hydatid echinococcosis [only with total pericystectomy]) and malignant tumors (colorectal cancer metastases in the liver [CRLM], hepatocellular carcinoma [HCC], intrahepatic cholangiocellular carcinoma, gallbladder cancer T1b-3NxMo without invasion into bile ducts and adjacent organs), which involves laparoscopic segmental or major resection of the liver.
- •Gender: both, male and female
- •Minimum age 18 years
- •Maximum age: 80 years
- •ASA physical status I-IV
- •BMI up to 40 kg/m2
- •No simultaneous extrahepatic intra-abdominal procedures (bile duct resection, colon resection, partial duodenum resection)
- •Total bilirubin up to 100mmol/l if jaundice presents in non-cirrhotic patients
- •If cirrhosis is present, class A and B according to CTP score
排除标准
- •• Difficulty index > 12 points (see below)
- •Tumor invasion of IVC or portal trunk (necessity of vascular reconstruction)
- •Repeated liver resection before laparoscopic resection (the single resection before is not a contraindication)
- •Simultaneous extra-hepatic intra-abdominal procedures (bile duct resection, colon resection etc.)
- •Age under 18 years
- •Age above 80 years
- •ASA physical status >IV
- •BMI > 40 kg/m2
- •Total bilirubin >100mmol/l if jaundice presents in non-cirrhotic patients
- •If cirrhosis is present, class C according to CTP score
- •Persons who are incapable of giving consent
- •Pregnant or breast-feeding women
- •Patients enlisted in other studies
研究组 & 干预措施
ErbeJet
liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).
干预措施: liver transection during laparoscopic liver resection (Procedure)
Misonix
liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)
干预措施: liver transection during laparoscopic liver resection (Procedure)
结局指标
主要结局
Intraoperative Blood Loss
时间窗: 1 day
Absolute blood loss (ml) will be calculated as the amount of blood (collected only during the parenchyma resection) in suction the container after the subtraction of all irrigating fluids and weighing operative sponges.
次要结局
- Аbsolute Measurement of Blood Loss in Relation to Resection Size (ml/cm^2)(1 day)
- Duration of Liver Parenchyma Transaction(1 day)
- Necessity to Apply the Pringle Maneuver.(1 day)
- Hospital Stay (Day)(up to 1 month)
- The Total Duration of Pringle Maneuver.(1 day)
研究者
Ivan Kazakov
Clinial Research
Moscow Clinical Scientific Center