Clinical trial NCT02563158: Study of Liver Resection With Versus Without Hepatic Inflow Occlusion for the HBV-related HCC
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cancer
Surgery
Keywords: liver resection
blood inflow control
ischemia-reperfusion injury
inflammatory response
randomized controlled trial
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum total bilirubin on postoperative day 5
timeFrame: 5 days
Secondary outcomes:
measure: Intraoperative blood loss
timeFrame: Entire operation duration
measure: Requirement of blood transfusion
timeFrame: Entire operation duration
measure: Operative time
timeFrame: Entire operation duration
measure: Postoperative intensive-care unit (ICU) stay
timeFrame: Duration of stay in ICU
measure: Hospital stay
timeFrame: Duration of hospital stay
measure: Total hospital expenditure
timeFrame: Duration of hospital stay
measure: Perioperative systemic inflammatory response
timeFrame: an expected average of 7 days
measure: Postoperative morbi-mortality
timeFrame: an expected average of 12 days in hospital
measure: Long-term oncologic outcomes
timeFrame: 5 years after operation
measure: Long-term survival
timeFrame: 5 years after operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Department of Hepatobiliary Surgery, Chinese PLA General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China
name: Shichun Lu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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