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

Not Applicable

• Conditions: Surgery; Liver Cancer
• Interventions: Procedure: non-occlusion technique

• Registration Number: NCT02563158
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2015-09-26
• Study First Submitted QC: 2015-09-28
• Study First Posted: 2015-09-30
• Study Start: 2016-01
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-12
• Primary Completion: 2019-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 114

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hx with non-occlusion technique	non-occlusion technique	Hepatectomy without hepatic inflow occlusion (non-occlusion technique)

Primary Outcome Measures

Name	Time	Method
Serum total bilirubin on postoperative day 5	5 days	Postoperative liver insufficiency characterized by the serum total bilirubin on POD 5.

Secondary Outcome Measures

Name	Time	Method
Requirement of blood transfusion	Entire operation duration	The amount of intraoperative blood transfusion
Hospital stay	Duration of hospital stay	Duration of hospital stay
Long-term survival	5 years after operation	1, 3, 5-year overall survival (OS) and disease (tumor)-free survival (DFS)
Total hospital expenditure	Duration of hospital stay	Total costs during hospital stay
Long-term oncologic outcomes	5 years after operation	1, 3, 5-year tumor recurrence rate
Intraoperative blood loss	Entire operation duration	Total blood loss from the incision to the closure of abdomen
Operative time	Entire operation duration	The time from induction of anesthesia to the closure of abdomen
Postoperative intensive-care unit (ICU) stay	Duration of stay in ICU	Duration of stay in ICU
Postoperative morbi-mortality	an expected average of 12 days in hospital	Postoperative morbi-mortality is characterized by postoperative complication and its severity based on Clavien-Dindo classification and in-hospital mortality
Perioperative systemic inflammatory response	an expected average of 7 days	Perioperative systemic inflammatory response is characterized by elevated serum level of tumor necrosis factor-α (TNF-α), interleukins (IL)-1α, 2, 6, 8 and 10, procalcitonin (PCT) and C-reactive protein (CRP) at different time points.

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China