Clinical Trial: Prevention of the Hepatic Sinusoidal Obstruction Syndrome by Means of Anticoagulants

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Prevention of the Hepatic Sinusoidal Obstruction Syndrome Secondary to Oxaliplatin-based Neoadjuvant Chemotherapy for Colorectal Liver Metastases by Means of Anticoagulant

Brief Summary: The purpose of the study is to determine whether anticoagulant use (i.e. salicylates, clopidogrel, low-molecular weight heparin, or coumarin derivates) is able to prevent the development of the sinusoidal obstruction syndrome secondary to oxaliplatin-based neoadjuvant chemotherapy in patients suffering from colorectal liver metastases.

Detailed Summary: Surgical resection remains the only curative treatment for patients suffering from colorectal liver metastases, but only 15-25% of patients are initially eligible for resection. The majority of patients suffering from colorectal liver metastases receives chemotherapy prior to liver surgery in order to downsize the colorectal liver metastases. Preoperative treatment with oxaliplatin-based chemotherapy is related to sinusoidal injury, the so-called sinusoidal obstruction syndrome. Patients with histologically proven sinusoidal injury undergoing liver surgery have a higher risk of post-resectional morbidity. Damage to the hepatic sinusoids is a key factor for the development of the sinusoidal obstruction syndrome. Anticoagulants (i.e. salicylates, clopidogrel, low-molecular weight heparin, or coumarin derivates) might be able to prevent this damage and, consequently, the development of the sinusoidal obstruction syndrome in patients suffering from colorectal liver metastases treated with neoadjuvant chemotherapy.
Sponsor: Maastricht University Medical Center

Current Primary Outcome: Histologically proven hepatic sinusoidal injury [ Time Frame: during liver surgery ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 90-day morbidity and mortality [ Time Frame: up until 90 days after surgery ]

Original Secondary Outcome: Same as current

Information By: Maastricht University Medical Center

Dates:
Date Received: April 21, 2009
Date Started: January 2008
Date Completion:
Last Updated: February 3, 2014
Last Verified: February 2014