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
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 90-day morbidity and mortality [ Time Frame: up until 90 days after surgery ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00885950     History of Changes
Other Study ID Numbers: 08-4-076
Study First Received: April 21, 2009
Last Updated: February 3, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

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

ClinicalTrials.gov processed this record on August 21, 2014