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Completed

NCT Number: NCT00885950

Prevention of the Hepatic Sinusoidal Obstruction Syndrome by Means of Anticoagulants

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.

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Key information

Conditions

Sinusoidal Obstruction Syndrome Cardiovascular Diseases Colorectal Liver Metastases Digestive System Diseases Hepatic Veno-Occlusive Disease Liver Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Surgery; Maastricht University Medical Centre

Maastricht, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Histologically proven hepatic sinusoidal injury

    Time frame: during liver surgery

Secondary outcomes

  1. 90-day morbidity and mortality

    Time frame: up until 90 days after surgery

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Apr 22, 2009
Registry last updated
Feb 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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