NCT03422913

Controlled Low Central Venous Pressure Combined With Hilar Block in Laparoscopic Hepatectomy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Hepatectomy is the preferred method for the treatment of liver tumors. Since the liver is a double blood supply organ, massive hemorrhage during hepatectomy may lead to hemodynamic instability, prolonged portal vein occlusion and increased ischemia-reperfusion injury. In addition, bleeding during hepatectomy, intraoperative and postoperative blood transfusion are the main causes of postoperative morbidity and mortality. Therefore, bleeding control during liver resection is a critical technique. Based on the fact that liver is more tolerant to warm ischemia and hypoxia, a variety of techniques have been widely used for hepatic blood flow occlusion. With the prevalence of laparoscopy, more patients received laparoscopic resection of liver cancer. Bleeding has become a major constraint, so how to reduce the bleeding and preserve liver function has always been surgeons' concern.As conventional hepatic portal blood flow blocking technology is more mature, the risk of bleeding during laparoscopic liver resection mainly comes from hepatic veins in the process of hepatic parenchymal isolation. Although Ultrasound scalpel and Ligasure have been widely accepted in the treatment of laparoscopic hepatectomy, due to the thin hepatic vein and the high intraluminal pressure, it is also difficult to control the bleeding during surgery. How to prevent hepatic venous hemorrhage has become the key to reduce the bleeding . As sinusoidal pressure is affected by intrahepatic pressure, which is directly related to central venous pressure (CVP), reducing CVP can reduce the pressure in the hepatic veins and sinusoids hence reducing bleeding when the hepatic parenchyma is severed. That is the rationale of controlled low central venous pressure CLCVP) to reduce the risk of hepatectomy, which have been used maturely in open hepatectomy. Due to the low risk of hepatic and renal insufficiency and gas embolism in liver surgery, there is a potential risk of laparoscopic pneumoperitoneum and the risk of laparoscopic pneumoperitoneum is further increased. Therefore, how to implement CLCVP in laparoscopic surgery to reduce the risk of bleeding, also avoiding complications such as bleeding gas embolism, is a clinical problem to be solved, is rarely reported. A prospective randomized controlled trial (RCT) will be performed for laparoscopic hepatectomy in patients combine intraoperative combined hilar intermittent (Pringle method) with or without CLCVP to reduce the bleeding. This study was to investigate the safety and efficacy of CLCVP in combination with intermittent Pringle.

Conditions

• Laparoscopic Hepatectomy

Interventions

Type	Name	Description
PROCEDURE	controlled low central venous pressure	Anesthesiologists will control the amount of fluid input and the use of composite intravenous anesthesia to make CVP at 0\~5cm H2O, if CVP is still \>5cm H2O, intravenous infusion of nitroglycerin will be used to reduce CVP. Maintaining arterial systolic blood pressure (SBP) \> 90 mmHg, urine output more than 1ml/kg/h, and CVP was continuously monitored. Arterial pressure, pulse oxygen saturation ( SPO2), PaCO2 and electrocardiogram (II and V5 leads) were continuously monitored by radial artery cannulation. CVP will Returned to normal level (6 \~ 12 cmH2O) after resection to observe the wound if active bleeding still exist. Intraoperative hepatic blood flow blocking intermittent Pringle block method also required during surgery, 10-15 minutes for once, and more than 5 minutes interval can be repeated.

Timeline

• Start date: 2017-07-01
• Primary completion: 2018-06-30
• Completion: 2018-06-30
• First posted: 2018-02-06
• Last updated: 2018-02-06

Locations

1 site across 1 country: China