NCT01819688

Brief Summary

The purpose of this study is to determine whether the postoperative insulin resistance and cytokine release would be attenuated in laparoscopic compared with open liver resection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2007

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

August 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed
Last Updated

March 27, 2013

Status Verified

March 1, 2013

Enrollment Period

1.3 years

First QC Date

March 20, 2013

Last Update Submit

March 22, 2013

Conditions

Insulin Resistance

Keywords

laparoscopic liver resectioncytokine release

Outcome Measures

Primary Outcomes (1)

  • postoperative insulin resistance calculated by serum insulin and blood glucose

    At baseline prior to surgery, and 3hr, 12hr, 24hr, 72hrs after operation, blood glucose and insulin was measured. Insulin resistance is assessed by the HOMAIR(homeostatic model assessment of insulin resistance) score which is calculated through the mathematic formula: HOMAIR= FI ×FG/22.5, where FI= fasting serum insulin(μU/mL), FG= fasting plasma glucose (mmol/L), and 22.5 is a constant.

    within the first 72hrs after operation

Secondary Outcomes (1)

  • cytokine changement including IL-1β, IFN-γ, IL-4 and IL-10 before and after operation

    within 5 days after operation

Interventions

laparoscopic liver resectionPROCEDURE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1-2
  • left hemihepatectomy(liver resection)
  • left lateral sectionectomy(liver resection)

You may not qualify if:

  • Patients with diabetes mellitus
  • drug abuse
  • BMI \>24 or \<18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310016, China

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. , Ph.D

Study Record Dates

First Submitted

March 20, 2013

First Posted

March 27, 2013

Study Start

August 1, 2007

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

March 27, 2013

Record last verified: 2013-03

Locations

CN(1)