Resection vs. Best Supportive Care for Hepatocellular Carcinoma (HCC) With Portal Venous Thrombus
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Hepatocellular Carcinoma With Portal Vein Tumor Thrombus |
Procedure: Liver resection plus Thrombectomy |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Surgical Resection Versus Best Supportive Care for Resectable Hepatocellular Carcinoma Invading the First Branch of Portal Vein |
- Survival time [ Time Frame: 5-years ] [ Designated as safety issue: No ]
- 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.
| Enrollment: | 126 |
| Study Start Date: | January 2006 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| China, Guangdong | |
| Cancer Center, Sun Yat-sen University | |
| Guangzhou, Guangdong, China, 510060 | |
| Principal Investigator: | Ming Shi, MD. | Sun Yat-sen University |
More Information
Additional Information:
Publications:
| Responsible Party: | Shi Ming, Professor, Sun Yat-sen University |
| ClinicalTrials.gov Identifier: | NCT01600196 History of Changes |
| Other Study ID Numbers: | HCC2005009 |
| Study First Received: | May 13, 2012 |
| Last Updated: | May 15, 2012 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Sun Yat-sen University:
|
Hepatectomy Thrombectomy Hepatocellular carcinoma Portal vein tumor thrombus |
Additional relevant MeSH terms:
|
Carcinoma Thrombosis Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Embolism and Thrombosis Vascular Diseases |
Cardiovascular Diseases Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on May 21, 2013