Ignite Creation Date:
2024-05-05 @ 11:33 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01350206
Status:
UNKNOWN
Last Update Posted:
2011-05-09
First Post:
2011-05-06
Brief Title:
Hepatic Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma Complicated by Portal Vein Tumor Thrombosis
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Hepatic Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma Complicated by Portal Vein Tumor ThrombosisA Prospective and Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2010-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The treatment for Hepatocellular Carcinoma HCC with Portal Vein Tumor Thrombosis PVTT is still controversial and there is no universally agreed protocol for its treatment Transarterial chemoembolization TACE has become the most popular palliative treatment for patients with unresectable HCC and it is no longer considered as a contraindication to HCC with PVTT Unfortunately the long term outcomes are generally poor for HCC treated with TACE especially for HCC with PVTT HR remains the only therapeutic option that may still offer a chance of cure With advances in surgical techniques it has become feasible to remove all gross tumors including PVTT which has extended to the main portal vein safely by surgery This study aimed to evaluate the safety and efficacy of HR as compared with TACE to treat patients with HCC with PVTT The investigators also aimed to identify patient groups that might benefit more from either treatment with HR or TACE
Detailed Description:
Hepatocellular carcinoma HCC is the sixth most common cancer and the third most frequent cause of cancer death worldwide Hepatic resection HR is the conventional curative treatment for HCC In both the European and the Unit States Proposed Guidelines for HCC HR is recommended only for patients with preserved liver function and with a single HCC lesion Unfortunately because of tumor multifocality portal vein invasion and underlying advanced cirrhosis only 10-30 of HCCs are amenable to such a curative treatment at the time of diagnosis Transarterial chemoembolization TACE has become the most popular palliative treatment for patients with unresectable HCC and it is no longer considered as a contraindication to HCC with portal vein tumor thrombus PVTT Unfortunately the long term outcomes are generally poor for HCC treated with TACE especially for HCC with PVTT
To improve on the results of treatment of HCC with PVTT attempts have been made to perform HR for these patients HCC with PVTT remains a contraindication to liver transplantation because of the high rate of tumor recurrence and because of the severe shortage of donor organs HR remains the only therapeutic option that may still offer a chance of cure With advances in surgical techniques it has become feasible to remove all gross tumors including PVTT which has extended to the main portal vein safely by surgery More HCC with PVTT which previously were considered as unresectable have become resectable Recent studies have even shown favorable long-term survival outcomes of HR in well-selected cases of HCC with PVTT However the survival outcomes of patients with HCC with PVTT treated with HR or with TACE have not been properly compared
This study aimed to evaluate the safety and efficacy of HR as compared with TACE to treat patients with HCC with PVTT The investigators also aimed to identify patient groups that might benefit more from either treatment with HR or TACE
To improve on the results of treatment of HCC with PVTT attempts have been made to perform HR for these patients HCC with PVTT remains a contraindication to liver transplantation because of the high rate of tumor recurrence and because of the severe shortage of donor organs HR remains the only therapeutic option that may still offer a chance of cure With advances in surgical techniques it has become feasible to remove all gross tumors including PVTT which has extended to the main portal vein safely by surgery More HCC with PVTT which previously were considered as unresectable have become resectable Recent studies have even shown favorable long-term survival outcomes of HR in well-selected cases of HCC with PVTT However the survival outcomes of patients with HCC with PVTT treated with HR or with TACE have not been properly compared
This study aimed to evaluate the safety and efficacy of HR as compared with TACE to treat patients with HCC with PVTT The investigators also aimed to identify patient groups that might benefit more from either treatment with HR or TACE
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None