Prevention of the Hepatic Sinusoidal Obstruction Syndrome by Means of Anticoagulants

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00885950

Enrollment

Registered

2009-04-22

Start date

2008-01-31

Completion date

2010-06-30

Last updated

2014-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Liver Metastases, Sinusoidal Obstruction Syndrome

Keywords

colorectal liver metastases, neoadjuvant chemotherapy, oxaliplatin, sinusoidal obstruction syndrome, anticoagulants

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Histologically proven hepatic sinusoidal injury	during liver surgery

Secondary

Measure	Time frame
90-day morbidity and mortality	up until 90 days after surgery

Countries

Netherlands

Outcome results