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


Phase 4
18 Years
75 Years
Not Enrolling
Both
Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

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Trial Information

Surgical Resection Versus Best Supportive Care for Resectable Hepatocellular Carcinoma Invading 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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival time

Outcome Time Frame:

5-years

Safety Issue:

No

Principal Investigator

Ming Shi, MD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University

Authority:

China: Ministry of Health

Study ID:

HCC2005009

NCT ID:

NCT01600196

Start Date:

January 2006

Completion Date:

July 2011

Related Keywords:

  • Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
  • Hepatectomy
  • Thrombectomy
  • Hepatocellular carcinoma
  • Portal vein tumor thrombus
  • Carcinoma
  • Thrombosis
  • Carcinoma, Hepatocellular

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