Prevention of the Hepatic Sinusoidal Obstruction Syndrome by Means of Anticoagulants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00885950
First received: April 21, 2009
Last updated: February 3, 2014
Last verified: February 2014

April 21, 2009
February 3, 2014
January 2008
December 2009   (final data collection date for primary outcome measure)
Histologically proven hepatic sinusoidal injury [ Time Frame: during liver surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00885950 on ClinicalTrials.gov Archive Site
90-day morbidity and mortality [ Time Frame: up until 90 days after surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples Without DNA
Description:

Paraffin embedded liver tissue

Probability Sample

Patients suffering from colorectal liver metastases who have undergone a partial hepatic resection

  • Sinusoidal Obstruction Syndrome
  • Colorectal Liver Metastases
Not Provided
Colorectal liver metastases
Patients with colorectal liver metastases undergoing partial hepatic resection who were preoperatively treated with either neoadjuvant chemotherapy or not and/or anticoagulants or not
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
June 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00885950
08-4-076
Yes
Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Principal Investigator: Steven WM Olde Damink, MD, PhD, MSc Maastricht University Medical Centre
Principal Investigator: Rob Jansen, MD, PhD Maastricht University Medical Centre
Maastricht University Medical Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP