NCT00887887

Brief Summary

The purpose of the study is to test whether the presence of polymorphisms in genes encoding substances of the innate immune response in patients undergoing partial hepatic resection because of benign or malignant hepatobiliary disease is related to a higher incidence of infectious complications, post-resectional liver failure or mortality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 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 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

October 15, 2014

Status Verified

October 1, 2014

Enrollment Period

2.4 years

First QC Date

April 23, 2009

Last Update Submit

October 13, 2014

Conditions

Liver Disease

Keywords

liver surgerygene polymorphismsinnate immune responseinfectious complicationspost-resectional liver failuremortality

Outcome Measures

Primary Outcomes (1)

  • clinically significant infectious complications (i.e. wound infection, pneumonia, blood stream infection, gastro-intestinal infection, intra-abdominal infection, urinary tract infection and miscellaneous)

    90 days after liver surgery

Secondary Outcomes (2)

  • post-resectional liver failure

    90 days after liver surgery

  • mortality

    90 days after liver surgery

Study Arms (1)

liver surgery

patients with benign or malignant hepatobiliary disease requiring partial hepatic resection

Eligibility Criteria

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

Patients with benign or malignant liver disease requiring partial hepatic resection at the Maastricht University Medical Centre

You may qualify if:

  • age \>18 years
  • benign or malignant liver disease requiring partial hepatic resection

You may not qualify if:

  • inability to give informed consent
  • liver disease judged irresectable after intra-operative evaluation
  • use of immunosuppressive drugs
  • resection \< 1 segment
  • unable to comply with follow-up

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 WITH DNA

whole blood, fresh frozen liver tissue

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Steven WM Olde Damink, MD, PhD, MSc

    Maastricht University Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 23, 2009

First Posted

April 24, 2009

Study Start

January 1, 2008

Primary Completion

June 1, 2010

Study Completion

January 1, 2014

Last Updated

October 15, 2014

Record last verified: 2014-10

Locations

NL(1)