Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028626
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2002-01-04
Brief Title:
Portal Vein Embolization in Treating Patients With Liver Metastases From Primary Colorectal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Clinical Efficacy And Biologic Effects Of Preoperative Portal Vein Embolization In Patients With Colorectal Liver Metastases
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
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:
RATIONALE Embolization blocks blood flow to part of an organ andor tumor Blocking the portal vein on one side of the liver may cause the opposite side of the liver to increase in size and decrease the risk of liver failure following surgery
PURPOSE Phase II trial to study the effectiveness of portal vein embolization in treating patients who have liver metastases from primary colorectal cancer
PURPOSE Phase II trial to study the effectiveness of portal vein embolization in treating patients who have liver metastases from primary colorectal cancer
Detailed Description:
OBJECTIVES
Determine whether portal vein embolization results in significant hypertrophy of the remaining liver and potentially decreases the risk of liver failure after hepatic resection in patients with liver metastases from primary colorectal cancer
Determine the biologic effects of this therapy on liver metastases and normal liver parenchyma in these patients
OUTLINE Patients undergo portal vein embolization with 200-300 micron polyvinyl chloride particles suspended in Iohexol 300 Approximately 3-6 weeks after embolization patients undergo an exploratory laparotomy followed by hepatic surgical resection
Patients are followed for at least 6 months
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study
Determine whether portal vein embolization results in significant hypertrophy of the remaining liver and potentially decreases the risk of liver failure after hepatic resection in patients with liver metastases from primary colorectal cancer
Determine the biologic effects of this therapy on liver metastases and normal liver parenchyma in these patients
OUTLINE Patients undergo portal vein embolization with 200-300 micron polyvinyl chloride particles suspended in Iohexol 300 Approximately 3-6 weeks after embolization patients undergo an exploratory laparotomy followed by hepatic surgical resection
Patients are followed for at least 6 months
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G01-2039 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000069112 | REGISTRY | None | None |