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

This study has been completed.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT01600196
First received: May 13, 2012
Last updated: May 15, 2012
Last verified: May 2012

May 13, 2012
May 15, 2012
January 2006
July 2009   (final data collection date for primary outcome measure)
Survival time [ Time Frame: 5-years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01600196 on ClinicalTrials.gov Archive Site
Number of Adverse Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Number of adverse events, and number of patients who developed adverse event. Postoperative adverse events were graded based on the Clavien-Dindo classification.
Same as current
Not Provided
Not Provided
 
Resection vs. Best Supportive Care for Hepatocellular Carcinoma (HCC) With Portal Venous Thrombus
Surgical Resection Versus Best Supportive Care for Resectable Hepatocellular Carcinoma Invading the First Branch of Portal Vein

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
Procedure: Liver resection plus Thrombectomy
Liver resection plus Thrombectomy
Other Name: Removal of all tumor tissue by surgery
  • Experimental: Resection arm
    Liver resection Plus Thrombectomy
    Intervention: Procedure: Liver resection plus Thrombectomy
  • No Intervention: Best support care arm
    Best supportive care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
July 2011
July 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01600196
HCC2005009
Yes
Shi Ming, Sun Yat-sen University
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
Sun Yat-sen University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP