Effect of an Artificial Pancreas in Patients Undergoing Hepatic Resection

April 15, 2008 updated by: Kochi University

Prevention for Surgical Site Infection After Hepatic Resection

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kochi
      • Nankoku-City, Kochi, Japan, 783-8505
        • Kochi Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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)
artificial pancreas
Other Names:
  • an artificial pancreas system (Nikkiso Inc, Tokyo, Japan)
No Intervention: 2
glucose levels were controlled using a manual injection of insulin according to the commonly used sliding scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the incidence of surgical site infection
Time Frame: 30th postoperative day
30th postoperative day

Secondary Outcome Measures

Outcome Measure
Time Frame
the incidence of hypoglycemia and cost during the hospitalization
Time Frame: during the hospitalization
during the hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kochi University

Investigators

  • Study Director: Takehiro Okabayashi, MD, Kochi Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

April 11, 2008

First Submitted That Met QC Criteria

April 15, 2008

First Posted (Estimate)

April 16, 2008

Study Record Updates

Last Update Posted (Estimate)

April 16, 2008

Last Update Submitted That Met QC Criteria

April 15, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TGC-AP-02
  • Kochi University

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

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