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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01600196

Enrollment

126

Registered

2012-05-16

Start date

2006-01-31

Completion date

2011-07-31

Last updated

2019-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

Keywords

Hepatectomy, Thrombectomy, Hepatocellular carcinoma, Portal vein tumor thrombus

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.

Interventions

PROCEDURELiver resection plus Thrombectomy

Liver resection plus Thrombectomy

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Survival time	5-years

Secondary

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026