Surgical Resection Versus Best Supportive Care for Resectable Hepatocellular Carcinoma Invading the First Branch of Portal Vein
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
- Sponsor
- Sun Yat-sen University
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- Survival time
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the long-term efficacy and safety of surgical resection compared with best supportive care in patients with resectable hepatocellular carcinoma (HCC) with portal venous thrombus (PVTT) in the first branch of portal vein.
Detailed Description
Advances in surgical techniques have made it possible to remove all macroscopic tumors in more hepatocellular carcinoma (HCC) patients with portal venous thrombus (PVTT). However, the benefit of such surgery remains largely controversial. On one hand, many clinicians believe that surgical resection offers the only chance for long term survival. Many studies reported a median survival of 6-40 months after liver resection and thrombectomy, and some cases achieved long term survival.On the other hand, the strength of evidences arising from these studies was widely questioned because of their retrospective nature and study design. Most of them were single arm cohort study. A few studies used control groups consisted of patients with unresectable HCC and PVTT underwent transarterial chemoembolization. This led to obvious selection bias. Because patients with unresectable HCC and PVTT have a much poorer prognosis compared with resectable disease because of more widespread tumor focus and less residual liver, even if their baseline characters are comparable.
Investigators
Shi Ming
Professor
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •The diagnosis of HCC was made according to AASLD guidelines
- •Main tumor ≥ 7 cm
- •Imaging confirmed the presence of PVTT in the first branches but not
- •Extend into the main trunk of portal vein
- •Eastern Co-operative Group performance
- •Resectable disease
Exclusion Criteria
- •Child-Pugh class B or C liver cirrhosis
- •An American Society of Anesthesiologists (ASA) score ≥ 3
- •Extrahepatic metastasis
- •Patients had access to sorafenib.
Outcomes
Primary Outcomes
Survival time
Time Frame: 5-years
Secondary Outcomes
- Number of Adverse Events(30 days)