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Portal Vein Embolization in Treating Patients With Liver Metastases From Primary Colorectal Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center Identifier:
First received: January 4, 2002
Last updated: June 4, 2013
Last verified: June 2013

RATIONALE: Embolization blocks blood flow to part of an organ and/or 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.

Condition Intervention Phase
Colorectal Cancer Metastatic Cancer Drug: embolization therapy Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Clinical Efficacy And Biologic Effects Of Preoperative Portal Vein Embolization In Patients With Colorectal Liver Metastases

Resource links provided by NLM:

Further study details as provided by Memorial Sloan Kettering Cancer Center:

Study Start Date: August 2001
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed primary colorectal adenocarcinoma with metastases to the liver being considered for hepatic resection
  • Requirement for removal of at least 60% of functional liver parenchyma based on CT scan
  • No extrahepatic disease by laparoscopy



  • Over 18

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • WBC at least 2,000/mm3
  • Platelet count at least 100,000/mm3


  • Bilirubin no greater than 1.8 mg/dL
  • AST and ALT no greater than 80 IU/L


  • Creatinine no greater than 1.8 mg/dL


  • No New York Heart Association class III or IV heart disease


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • Not specified


  • At least 1 month since prior systemic chemotherapy

Endocrine therapy:

  • Not specified


  • Not specified


  • See Disease Characteristics


  • At least 2 months since prior investigational treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00028626

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Ronald DeMatteo, MD Memorial Sloan Kettering Cancer Center
  More Information Identifier: NCT00028626     History of Changes
Other Study ID Numbers: 01-113
CDR0000069112 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: January 4, 2002
Last Updated: June 4, 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
liver metastases
adenocarcinoma of the colon
recurrent colon cancer
stage IV colon cancer
adenocarcinoma of the rectum
recurrent rectal cancer
stage IV rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes processed this record on September 19, 2017