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

Hepatocellular Carcinoma With Portal Vein Tumor Thrombus Clinical Trial

Official title:

Surgical Resection Versus Best Supportive Care for Resectable Hepatocellular Carcinoma Invading the First Branch of Portal Vein

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01600196
• Other study ID #: HCC2005009
• Status: Terminated
• Phase: Phase 4
• Start date: January 2006
• Est. completion date: July 2011

Study information

• Verified date: January 2019
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 126
• Est. completion date: July 2011
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
• Thrombosis

Intervention

Procedure:
• Liver resection plus Thrombectomy
Liver resection plus Thrombectomy

Locations

Country	Name	City	State
China	Cancer Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
Sun Yat-sen University	Guangzhou 8th People's Hospital, Kaiping Central Hospital, The 458 Hospital of Chinese People's Liberation Army

Country where clinical trial is conducted

China, 

References & Publications (1)

Le Treut YP, Hardwigsen J, Ananian P, Saïsse J, Grégoire E, Richa H, Campan P. Resection of hepatocellular carcinoma with tumor thrombus in the major vasculature. A European case-control series. J Gastrointest Surg. 2006 Jun;10(6):855-62. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival time		5-years
Secondary	Number of Adverse Events	Number of adverse events, and number of patients who developed adverse event. Postoperative adverse events were graded based on the Clavien-Dindo classification.	30 days

External Links

•   web site of Cancer Center, Sun Yat-sen University