Prevention of the Hepatic Sinusoidal Obstruction Syndrome by Means of Anticoagulants

Colorectal Liver Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00885950
• Other study ID #: 08-4-076
• Status: Completed
• Phase: N/A
• First received: April 21, 2009
• Last updated: February 3, 2014
• Start date: January 2008
• Est. completion date: June 2010

Study information

• Verified date: February 2014
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Colorectal Liver Metastases
• Hepatic Veno-Occlusive Disease
• Liver Neoplasms
• Neoplasm Metastasis
• Sinusoidal Obstruction Syndrome
• Syndrome

Locations

Country	Name	City	State
Netherlands	Department of Surgery; Maastricht University Medical Centre	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histologically proven hepatic sinusoidal injury		during liver surgery	No
Secondary	90-day morbidity and mortality		up until 90 days after surgery	No