A Prospective Randomized Controlled Trial to Compare Infrahepatic Inferior Vena Cava Clamping With Selective Hepatic Vascular Exclusion Involving the Portal Triad Clamping in Hepatectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Normalized transection-related blood loss
研究概览
简要总结
This clinical trial aims to compare infrahepatic inferior vena cava clamping (IIVCC) with selective hepatic vascular exclusion (SHVE) involving the portal triad clamping (PTC) in complex cirrhotic liver resection. One group will receive IIVCC plus PTC, while an another equivalent group patients will be operated using SHVE and PTC.
详细描述
Intraoperative blood loss is significantly associated with clinical outcomes of patients undergoing hepatectomy. There have been various hepatic vascular control techniques, including infrahepatic inferior vena cava clamping (IIVCC) and selective hepatic vascular exclusion (SHVE).The propose of this study is to compare these two surgical techniques combined with the portal triad clamping (PTC) in hepatic cirrhotic patients. All patients being performed hepatectomy at the center are scanned according to inclusion and exclusion criteria. After intraoperative exploration, patients are randomized into two interventional groups. PTC, IIVCC or SHVE is performed at the specified timepoint in liver parenchymal transection in two different groups. All data are collected prospectively.
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 (Participant, Care Provider, Outcomes Assessor)
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
- •either male or female, older than 18 (include 18).
- •tumors oppress or be in close proximity to one or more of major hepatic veins.
- •the maximum diameter of tumor ≥ 5cm, number of lesions ≤ 3 and should be in same liver lobe if multiple lesions exit.
- •preoperative liver function assessment: Child-Pugh classification is A or B.
- •preoperative laboratory test: blood platlet count > 100×10^9/l, prothrombin activity > 60%.
- •liver cirrhosis.
排除标准
- •contraindication for surgery,e.g.severe disorders of circulation, respiratory or renal system.
- •extrahepatic metastasis in patients with malignancy or tumor invasion of portal vein, hepatic vein, bile duct or inferior vena cava.
- •hepatectomy accompanied with other organs resection(e.g. bile duct, intestine, pancreas or stomach)
- •regular hepatectomy.
- •tumors located in the left lateral lobe of liver.
- •previous hepatectomy.
- •pregnancy or lactation.
- •refusal to participate this trial.
研究组 & 干预措施
IIVCC group
The portal triad and infrahepatic inferior vena cava are dissected and taped with a vessel loop, respectively. During liver parenchymal resection，portal triad and infrahepatic inferior vena cava clampings are performed at the specified transection depth from liver surface successively.
干预措施: Infrahepatic inferior vena cava clamping (Procedure)
IIVCC group
The portal triad and infrahepatic inferior vena cava are dissected and taped with a vessel loop, respectively. During liver parenchymal resection，portal triad and infrahepatic inferior vena cava clampings are performed at the specified transection depth from liver surface successively.
干预措施: Portal triad clamping (Procedure)
SHVE group
In this group, the portal triad clamping and selective hepatic vascular exclusion of major hepatic veins are used. Different major hepatic veins are occluded by clamping forcep depending on the site of tumors. The clamping timepoints are same as the IIVCC group.
干预措施: Selective hepatic vascular exclusion (Procedure)
SHVE group
In this group, the portal triad clamping and selective hepatic vascular exclusion of major hepatic veins are used. Different major hepatic veins are occluded by clamping forcep depending on the site of tumors. The clamping timepoints are same as the IIVCC group.
干预措施: Portal triad clamping (Procedure)
结局指标
主要结局
Normalized transection-related blood loss
时间窗: Intraoperative period
Intraoperative blood loss normalized by transection surface area
Intraoperative blood loss
时间窗: Intraoperative period
blood loss from incision to closure
次要结局
- Postrecovery of liver function(postoperative days 1, 3, 5, 7)
- Postrecovery of renal function(postoperative days 1, 3, 5, 7)
- Morbidity of postoperative complications(90 days after surgery)
- Variations of intraoperative infrahepatic inferior vena cava pressure or hepatic vein pressure(Intraoperative period)
- Postoperative mortality(90 days after surgery)
- Drop of hemoglobin level(Drop of hemoglobin level will be measured during liver parenchymal transection period(neither the specific time point nor expected average could be given prospectively because of different surgical situations))
- Time of infrahepatic inferior vena cava or selected hepatic vein dissection(Intraoperative period)
研究者
Xiaoping Chen
Chairman and Professor of Department of Surgery
Huazhong University of Science and Technology