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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01600196
Recruitment Status : Completed
First Posted : May 16, 2012
Last Update Posted : May 16, 2012
Guangzhou 8th People's Hospital
Kaiping Central Hospital
The 458 Hospital of Chinese People's Liberation Army
Information provided by (Responsible Party):
Shi Ming, 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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma With Portal Vein Tumor Thrombus Procedure: Liver resection plus Thrombectomy Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgical Resection Versus Best Supportive Care for Resectable Hepatocellular Carcinoma Invading the First Branch of Portal Vein
Study Start Date : January 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arm Intervention/treatment
Experimental: Resection arm
Liver resection Plus Thrombectomy
Procedure: Liver resection plus Thrombectomy
Liver resection plus Thrombectomy
Other Name: Removal of all tumor tissue by surgery

No Intervention: Best support care arm
Best supportive care

Primary Outcome Measures :
  1. Survival time [ Time Frame: 5-years ]

Secondary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01600196

China, Guangdong
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Guangzhou 8th People's Hospital
Kaiping Central Hospital
The 458 Hospital of Chinese People's Liberation Army
Principal Investigator: Ming Shi, MD. Sun Yat-sen University

Additional Information:
Responsible Party: Shi Ming, Professor, Sun Yat-sen University Identifier: NCT01600196     History of Changes
Other Study ID Numbers: HCC2005009
First Posted: May 16, 2012    Key Record Dates
Last Update Posted: May 16, 2012
Last Verified: May 2012

Keywords provided by Shi Ming, Sun Yat-sen University:
Hepatocellular carcinoma
Portal vein tumor thrombus

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases