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

Chinese PLA General Hospital (301 Hospital)

Status: Unknown

Conditions: Surgery; Liver Cancer

Treatments: Procedure: non-occlusion technique

Study type: Interventional

Funder types: Other

Identifiers

NCT02563158

JFJZYY-GD-15-01

NO. 2012ZX10002-017 (Other Grant/Funding Number)

NO. 2012BAI06B01 (Other Grant/Funding Number)

Details and patient eligibility

About

The study aims to compare the perioperative and long-term outcomes of liver resection for HBV-related HCC with versus without hepatic inflow occlusion.

Full description

High prevalence of hepatitis B virus (HBV) imposes a huge burden of hepatocellular carcinoma (HCC) in Asia. Liver resection remains the mainstay of treatment for HCC. Hepatic inflow occlusion, known as the Pringle maneuver, is most commonly used to reduce blood loss during liver parenchymal transection. A major issue about this maneuver is the ischemia-reperfusion injury to the remnant liver. And the hemodynamic disturbance to the tumor-bearing liver remains an oncologic concern. Given the technical advances in living donor liver transplantation, vascular occlusion can be avoided in liver resection by experienced hands. This study aims to compare the perioperative and long-term outcomes of liver resection for HBV-related HCC without versus with hepatic inflow occlusion.

This study will include eligible patients with HBV-related HCC elected for liver resection. 57 patients will be enrolled in each randomized arm to detect a 20% difference in the serum level of total bilirubin on postoperative day 5 (80% power and α = 0.05). The secondary endpoints include procedural parameters, perioperative liver function and inflammatory response, postoperative morbidity and mortality, and long-term outcomes. Patients will be followed for up to five years. Data will be statistically analyzed on an intention-to-treat basis.

This prospective randomized controlled trial is designed to evaluate the feasibility of liver resections for HBV-related HCC without vascular occlusion. Clinical implication of its outcomes may change the present surgical practice and fill the oncologic gaps therein.

Enrollment: 114 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Elective liver resection due to HBV-related HCC with Barcelona-Clinic Liver Cancer (BCLC) staging 0 or A;
2. Child-Pugh classified A with or without cirrhosis, or reversed to A from B after conventional therapy;
3. Tumors located either in the left or right hemiliver;
4. Resection extent was a hemi-hepatectomy or less;
5. Informed consent.

Exclusion criteria

1. Having comorbidity that contraindicates surgery;
2. Participation in concurrent interventional trials with interference to this study;
3. Eligible for laparoscopic hepatectomy;
4. Requiring concomitant procedures, such as digestive, vascular or biliary reconstruction;
5. Lack of compliance for treatment or future follow-up.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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114 participants in 2 patient groups

Hx with hepatic inflow occlusion

No Intervention group

Description:

Hepatectomy is carried out using Pringle maneuver in cycles of 15 minutes clamping + 5 minutes unclamping of the hepatoduodenal ligament.

Hx with non-occlusion technique

Experimental group

Description:

Hepatectomy without hepatic inflow occlusion (non-occlusion technique)

Treatment:

Procedure: non-occlusion technique