Study of Liver Resection With Versus Without Hepatic Inflow Occlusion for the HBV-related HCC — OHx-NOHx  

Surgery Clinical Trial

Official title: Short- and Long-term Outcomes of Liver Resection With Versus Without Hepatic Inflow Occlusion for the Hepatitis B Virus-related Hepatocellular Carcinoma: a Prospective Randomized Controlled Trial

Status Not yet recruiting

Clinical Trial Summary

The study aims to compare the two liver resection techniques (with versus without hepatic inflow occlusion) in regards to perioperative and long-term outcomes of hepatectomy for HBV-related HCC.

Clinical Trial Description

Blood loss and the requirement of transfusions during liver resection have been shown to correlate well with postoperative morbidity and mortality. Total hepatic blood inflow occlusion, also known as the Pringle maneuver, is most commonly practiced for the control of bleeding during liver transection, which improves the surgical safety but also induces ischemia-reperfusion injury to the liver remnant as well as hemodynamic disturbance. These concerns are more profound in patients with hepatocellular carcinoma that are superimposed on hepatitis B cirrhosis. In the rise of living donor liver transplantation, techniques of donor liver lobe procurement without hepatic inflow occlusion have been established. This study aims to compare the outcomes of liver resection with versus without hepatic inflow occlusion.

This study will include Child-Pugh grading A patients with hepatitis B virus-related hepatocellular carcinoma scheduled for elective liver resection. 57 patients in each randomized arm will be analyzed to detect a difference in the short- and long-term outcomes (80% power and α = 0.05). The primary endpoint of the trial will be the serum level of total bilirubin on postoperative day 5. The secondary endpoints will be perioperative systemic response, procedure-related parameters, postoperative morbi-mortality and long-term patient outcomes. The statistical analysis is based on the intention-to-treat population. Patients will be followed for up to five years.

This prospective randomized controlled single-center trial is designed to evaluate liver resections with versus without the hepatic inflow occlusion with a special regard to the ischemia-reperfusion injury, perioperative systemic inflammatory response and long-term outcomes. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cancer
• Surgery

• NCT number: NCT02563158
• Study type: Interventional
• Source: Chinese PLA General Hospital
• Contact: Shichun Lu, MD, PhD
• Phone: +86 10 68160801
• Email: sclu_301@163.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2016
• Completion date: January 2019