Liver Regeneration After Liver Resection | NCT01220986

Studies
Liver Regeneration After Liver Resection

NCT01220986

Sponsor

Nottingham University Hospitals NHS Trust

Status

Unknown status

Last Update Posted

Oct 14, 2010Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Liver Diseases
Hepatectomy

Interventions

Liver biopsy

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Dec 2011Estimated

Completion Date

Aug 2012Estimated

First Submitted Date

Oct 13, 2010

First Submission Date that Met QC Criteria

Oct 13, 2010

First Posted Date

Oct 14, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2010

Last Update Posted Date

Oct 14, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Right hepatectomy		Intervals from inflow division.	Procedure: Liver biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Liver biopsy	Procedure	0, 30, 60, 90 min post inflow-division	Right hepatectomy

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients requiring right hepatectomy for colorectal liver metastases

Exclusion Criteria:

Age >75, neoadjuvant chemotherapy, recurrent disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing right hepatectomy for colorectal liver metastases.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
John S Hammond, BM.BS PhD	Contact	01159249924	70607	john.hammond@nottingham.ac.uk

Overall Officials

Name	Affiliation	Role
Dileep N. Lobo, DM FRCS	Reader in Surgery	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus	Recruiting	Nottingham	Nottinghamshire	NG7 2UH	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D008107	Liver Diseases

Ancestor Terms

ID	Term
D004066	Digestive System Diseases

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