NCT01220986

Brief Summary

The aim of this study is to characterize Kupffer cell activity and activation of the innate immune response in the early phase of liver regeneration after right hepatectomy. The investigators hypothesise that liver regeneration after right hepatectomy in humans is associated with Kupffer cell activation and initiation of the innate immune response and that impaired liver regeneration, liver failure and sepsis following liver resection are associated with Kupffer cell dysfunction and an impaired innate immune response. The objectives for this study are to characterise Kupffer cell activity and the innate immune response in human liver before and after right hepatectomy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

October 14, 2010

Status Verified

October 1, 2010

Enrollment Period

1.3 years

First QC Date

October 13, 2010

Last Update Submit

October 13, 2010

Conditions

Liver DiseasesHepatectomy

Keywords

Liver regenerationInnate immune response

Study Arms (1)

Right hepatectomy

Intervals from inflow division.

Procedure: Liver biopsy

Interventions

Liver biopsyPROCEDURE

0, 30, 60, 90 min post inflow-division

Right hepatectomy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing right hepatectomy for colorectal liver metastases.

You may qualify if:

  • Patients requiring right hepatectomy for colorectal liver metastases

You may not qualify if:

  • Age \>75, neoadjuvant chemotherapy, recurrent disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Liver tissue \& serum

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Dileep N. Lobo, DM FRCS

    Reader in Surgery

    STUDY CHAIR

Central Study Contacts

John S Hammond, BM.BS PhD

CONTACT

01159249924john.hammond@nottingham.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 13, 2010

First Posted

October 14, 2010

Study Start

August 1, 2010

Primary Completion

December 1, 2011

Study Completion

August 1, 2012

Last Updated

October 14, 2010

Record last verified: 2010-10

Locations

GB(1)