NCT00885950

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

February 4, 2014

Status Verified

February 1, 2014

Enrollment Period

1.9 years

First QC Date

April 21, 2009

Last Update Submit

February 3, 2014

Conditions

Sinusoidal Obstruction SyndromeColorectal Liver Metastases

Keywords

colorectal liver metastasesneoadjuvant chemotherapyoxaliplatinsinusoidal obstruction syndromeanticoagulants

Outcome Measures

Primary Outcomes (1)

  • Histologically proven hepatic sinusoidal injury

    during liver surgery

Secondary Outcomes (1)

  • 90-day morbidity and mortality

    up until 90 days after surgery

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • age \> 18 years
  • colorectal liver metastases that are eligible for resection
  • operated from January 2008 up until December 2009 at Maastricht University Medical Centre

You may not qualify if:

  • irresectable colorectal liver metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery; Maastricht University Medical Centre

Maastricht, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Paraffin embedded liver tissue

MeSH Terms

Conditions

Hepatic Veno-Occlusive Disease

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Steven WM Olde Damink, MD, PhD, MSc

    Maastricht University Medical Centre

    PRINCIPAL INVESTIGATOR

  • Rob Jansen, MD, PhD

    Maastricht University Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2009

First Posted

April 22, 2009

Study Start

January 1, 2008

Primary Completion

December 1, 2009

Study Completion

June 1, 2010

Last Updated

February 4, 2014

Record last verified: 2014-02

Locations

NL(1)