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Prevention of the Hepatic Sinusoidal Obstruction Syndrome by Means of Anticoagulants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00885950
First Posted: April 22, 2009
Last Update Posted: February 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maastricht University Medical Center
  Purpose
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.

Condition
Sinusoidal Obstruction Syndrome Colorectal Liver Metastases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prevention of the Hepatic Sinusoidal Obstruction Syndrome Secondary to Oxaliplatin-based Neoadjuvant Chemotherapy for Colorectal Liver Metastases by Means of Anticoagulants

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Histologically proven hepatic sinusoidal injury [ Time Frame: during liver surgery ]

Secondary Outcome Measures:
  • 90-day morbidity and mortality [ Time Frame: up until 90 days after surgery ]

Biospecimen Retention:   Samples Without DNA
Paraffin embedded liver tissue

Enrollment: 80
Study Start Date: January 2008
Study Completion Date: June 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients suffering from colorectal liver metastases who have undergone a partial hepatic resection
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00885950


Locations
Netherlands
Department of Surgery; Maastricht University Medical Centre
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Steven WM Olde Damink, MD, PhD, MSc Maastricht University Medical Centre
Principal Investigator: Rob Jansen, MD, PhD Maastricht University Medical Centre
  More Information

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00885950     History of Changes
Other Study ID Numbers: 08-4-076
First Submitted: April 21, 2009
First Posted: April 22, 2009
Last Update Posted: February 4, 2014
Last Verified: February 2014

Keywords provided by Maastricht University Medical Center:
colorectal liver metastases
neoadjuvant chemotherapy
oxaliplatin
sinusoidal obstruction syndrome
anticoagulants

Additional relevant MeSH terms:
Syndrome
Neoplasm Metastasis
Liver Neoplasms
Hepatic Veno-Occlusive Disease
Disease
Pathologic Processes
Neoplastic Processes
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Vascular Diseases
Cardiovascular Diseases
Oxaliplatin
Anticoagulants
Antineoplastic Agents