NCT03422913

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

Status unknown NA Last updated 6 February 2018

What this trial tests

NA trial testing controlled low central venous pressure in Laparoscopic Hepatectomy in 140 participants. Status unknown.

Timeline

1 July 2017

Primary endpoint
30 June 2018

30 June 2018

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	140
Start date	1 July 2017
Primary completion	30 June 2018
Estimated completion	30 June 2018
Sites	1 location across China

Drugs / interventions tested

• controlled low central venous pressure

Conditions studied

• Laparoscopic Hepatectomy — all drugs for Laparoscopic Hepatectomy →

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 70, any sex, with Laparoscopic Hepatectomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Intention to control low central venous pressure reduced blood loss during laparoscopic hepatectomy: A double-blind randomized clinical trial.
   Pan YX, Wang JC, Lu XY, Chen JB, et al · · 2020 · cited 19× · PMID 32216964 · DOI 10.1016/j.surg.2020.02.004