NCT00659698

Brief Summary

This study evaluated that strict control of perioperative blood glucose following hepatic resection by using an artificial pancreas would improve postoperative surgical site infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 16, 2008

Completed
Last Updated

April 16, 2008

Status Verified

April 1, 2008

Enrollment Period

1 year

First QC Date

April 11, 2008

Last Update Submit

April 15, 2008

Conditions

Liver Diseases

Keywords

surgicalsiteinfection

Outcome Measures

Primary Outcomes (1)

  • the incidence of surgical site infection

    30th postoperative day

Secondary Outcomes (1)

  • the incidence of hypoglycemia and cost during the hospitalization

    during the hospitalization

Study Arms (2)

1

EXPERIMENTAL

received programmed infusions of insulin determined by the control algorithm of the artificial pancreas

Device: the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)

2

NO INTERVENTION

glucose levels were controlled using a manual injection of insulin according to the commonly used sliding scale

Interventions

the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)DEVICE

artificial pancreas

Also known as: an artificial pancreas system (Nikkiso Inc, Tokyo, Japan)
1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • This study recruited 70 patients undergoing elective hepatic resection for liver diseases. Perioperative blood glucose concentration was continuously monitored using an artificial pancreas system.

You may not qualify if:

  • weight loss greater than 10% during the previous 6 months, signs of distant metastasis, and respiratory, renal, or heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kochi Medical School

Nankoku, Kochi, 783-8505, Japan

Location

MeSH Terms

Conditions

Liver DiseasesInfections

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Takehiro Okabayashi, MD

    Kochi Medical School

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 11, 2008

First Posted

April 16, 2008

Study Start

April 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

April 16, 2008

Record last verified: 2008-04

Locations

JP(1)