Short and Long Outcomes Between Laparoscopic and Open Hepatectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change of serum glutamic oxalacetic transaminase
研究概览
简要总结
LLR was applied for tumors located at the lower edge and lateral segments of the liver that could be resected more easily than posterosuperior segments. With the development of technology and the growing experience of hepatobiliary surgeons, LLR has been expanded to major liver resections, anatomical resections, and donor hepatectomies by skilled surgeons. However, due to the concerns over the risk of operative bleeding, tumor seeding and positive resection margin, the true benefit of LLR remains unclear across surgical community.
详细描述
The 2nd International Consensus Conference on Laparoscopic Liver Resection (ICCLLR) was held in Morioka, Japan, in 2014. The new recommendations of the ICCLLR state that the outcomes of LLR are not inferior than OLR regarding to operative mortality rate and margin negativity, and are superior in decreasing postoperative complications, blood loss, and the length of the postoperative hospital stay. However, it is not clear that whether LLR is able to alleviate the impairment of liver function after hepatic resection, and there is no RCTs to compare the short and long outcomes between LLR and OLR.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •Patient who underwent hepatectomy for benign or malignant neoplasm of the liver, and is suitable for both open and laparoscopic liver resection;
- •Child-Pugh A without portal hypertension
- •No portosystemic shunt
- •No previous abdominal operation history.
- •American society of anesthesiology class(ASA): I or II
- •Age 18 to 80
排除标准
- •Additional intervention to the liver (Radio Frequent Ablation, Percutaneous Ethanol. Injection Therapy or others)
- •Combined hepatectomy
- •Intrahepatic duct stone disease
- •Liver disease caused splenomegaly
- •Previous hepatectomy
- •Combined operation for extrahepatic disease
- •Vulnerable population (mental retardation, pregnancy)
研究组 & 干预措施
Laparoscopic liver resection
Laparoscopic hepatectomy
干预措施: Laparoscopic liver resection (Procedure)
Open liver resection
Open hepatectomy
干预措施: Open liver resection (Procedure)
结局指标
主要结局
Change of serum glutamic oxalacetic transaminase
时间窗: up to 7 days after liver resection
Change of serum glutamic oxalacetic transaminase after liver resection.These values will be recorded preoperative, and postoperative day-1,3,5,7.
Change of serum glutamic-pyruvic transaminase
时间窗: up to 7 days after liver resection
Change of serum glutamic-pyruvic transaminase after liver resection.These values will be recorded preoperative, and postoperative day-1,3,5,7.
次要结局
- Postoperative complication(Rates in different grades)(up to 30 days after liver resection)
- Mortality rates(up to 30 days after liver resection)
- Hospital duration after operation (days)(up to 30 days after liver resection)
- Intensive care unit stay (days)(up to 7 days after liver resection)
- Blood transfusion (times and units)(intraoperative)
- Duration of nasogastric tubes (hours)(up to 14 days after liver resection7)
- Duration to first flatus (days)(up to 14 days after liver resection)
- Resection margin status(up to 30 days after liver resection)
- Operation time(min)(up to 30 days after liver resection)
- Blood loss(ml)(up to 30 days after liver resection)
- Duration of abdominal drain (days)(up to 14 days after liver resection)
- Comfort questionnaire measures (GCQ) measures by Kolcaba(up to 7 days after liver resection)
- Readmission rate(up to 30 days after liver resection)
- C-reactive protein (mg/mL)(up to 5 days after liver resection)
- Disease recurrence rates(up to 5 years)
- Overall survival time (month)(up to 5 years after operation)
- Disease free survival time (month)(up to 5 years after operation)
研究者
hui hou
Director of the hepatobiliary surgery department
The Second Hospital of Anhui Medical University