Prevention of the Hepatic Sinusoidal Obstruction Syndrome by Means of Anticoagulants

Completed

• Conditions: Colorectal Liver Metastases; Sinusoidal Obstruction Syndrome

• Registration Number: NCT00885950
• Lead Sponsor: Maastricht University Medical Center

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 Description

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-04-21
• Study First Submitted QC: 2009-04-21
• Study First Posted: 2009-04-22
• Primary Completion: 2009-12
• Study Completion: 2010-06
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-03
• Last Update Posted: 2014-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• age > 18 years
• colorectal liver metastases that are eligible for resection
• operated from January 2008 up until December 2009 at Maastricht University Medical Centre

Exclusion Criteria

• irresectable colorectal liver metastases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Histologically proven hepatic sinusoidal injury	during liver surgery

Secondary Outcome Measures

Name	Time	Method
90-day morbidity and mortality	up until 90 days after surgery

Trial Locations

Locations (1)

Department of Surgery; Maastricht University Medical Centre; 🇳🇱 Maastricht, Netherlands