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Effect of an Artificial Pancreas in Patients Undergoing Hepatic Resection

NCT ID: NCT00659698

Last Updated: 2008-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-04-30

Brief Summary

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

Detailed Description

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This study recruited 70 patients undergoing elective hepatic resection for liver diseases. Perioperative blood glucose concentration was continuously monitored using an artificial pancreas system. We prospectively divided patients into two groups: one for whom glucose levels were controlled using a manual injection of insulin according to the commonly used sliding scale and another that received programmed infusions of insulin determined by the control algorithm of the artificial pancreas.

Conditions

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Liver Diseases

Keywords

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surgical site infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

artificial pancreas

2

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

artificial pancreas

Intervention Type DEVICE

Other Intervention Names

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an artificial pancreas system (Nikkiso Inc, Tokyo, Japan)

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kochi University

OTHER

Sponsor Role lead

Responsible Party

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Kochi Medical School

Principal Investigators

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Takehiro Okabayashi, MD

Role: STUDY_DIRECTOR

Kochi Medical School

Locations

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Kochi Medical School

Nankoku, Kochi, Japan

Site Status

Countries

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Japan

Other Identifiers

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Kochi University

Identifier Type: -

Identifier Source: secondary_id

TGC-AP-02

Identifier Type: -

Identifier Source: org_study_id