Clinical trial NCT00885950: Prevention of the Hepatic Sinusoidal Obstruction Syndrome by Means of Anticoagulants
Official title: Prevention of the Hepatic Sinusoidal Obstruction Syndrome Secondary to Oxaliplatin-based Neoadjuvant Chemotherapy for Colorectal Liver Metastases by Means of Anticoagulants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sinusoidal Obstruction Syndrome
Colorectal Liver Metastases
Keywords: colorectal liver metastases
neoadjuvant chemotherapy
oxaliplatin
sinusoidal obstruction syndrome
anticoagulants
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2009-04-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from colorectal liver metastases who have undergone a partial hepatic resection

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.

Eligibility criteria: 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

Primary outcomes:
measure: Histologically proven hepatic sinusoidal injury
timeFrame: during liver surgery
Secondary outcomes:
measure: 90-day morbidity and mortality
timeFrame: up until 90 days after surgery
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Department of Surgery; Maastricht University Medical Centre
Study officials:
affiliation: Maastricht University Medical Centre
name: Steven WM Olde Damink, MD, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Centre
name: Rob Jansen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: