Resection vs. Best Supportive Care for Hepatocellular Carcinoma (HCC) With Portal Venous Thrombus

Phase 4

Terminated

• Conditions: Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
• Interventions: Procedure: Liver resection plus Thrombectomy

• Registration Number: NCT01600196
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2009-07
• Study Completion: 2011-07
• Study First Submitted: 2012-05-13
• Study First Submitted QC: 2012-05-15
• Study First Posted: 2012-05-16
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-22
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 126

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resection arm	Liver resection plus Thrombectomy	Liver resection Plus Thrombectomy

Primary Outcome Measures

Name	Time	Method
Survival time	5-years

Secondary Outcome Measures

Name	Time	Method
Number of Adverse Events	30 days	Number of adverse events, and number of patients who developed adverse event. Postoperative adverse events were graded based on the Clavien-Dindo classification.

Trial Locations

Locations (1)

Cancer Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China