Prevention of the Hepatic Sinusoidal Obstruction Syndrome by Means of Anticoagulants

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sinusoidal Obstruction Syndrome, Colorectal Liver Metastases

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colorectal liver metastases<br>Patients with colorectal liver metastases undergoing partial hepatic resection who were preoperatively treated with either neoadjuvant chemotherapy or not and/or anticoagulants or not | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histologically proven hepatic sinusoidal injury |  | during liver surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-day morbidity and mortality |  | up until 90 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal liver metastases, neoadjuvant chemotherapy, oxaliplatin, sinusoidal obstruction syndrome, anticoagulants