Effect of an Artificial Pancreas in Patients Undergoing Pancreatic Resection

January 28, 2009 updated by: Kochi University

Prevention for Surgical Site Infection After Pancreatic Resection

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study recruited 50 patients undergoing elective pancreatic resection for pancreatic diseases. Perioperative blood glucose concentration was continuously monitored using an artificial pancreas system. We prospectively divided 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 infusion of insulin determined by the control algorithm of the artificial pancreas.

Study Type

Interventional

Enrollment (Anticipated)

50

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 Contact

Study Locations

  • Japan
    • Kochi
      • Nankoku-City, Kochi, Japan, 783-8505
        • Recruiting
        • Kochi Medical School
        • Contact:

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:

  • patients undergoing elective pancreatic resection for pancreatic diseases.

Exclusion Criteria:

  • weight loss greater than 10% during the previous 6 months
  • sign of distant metastasis
  • 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
No Intervention: 1
glucose levels were controlled using sliding scale
Experimental: 2
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)

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 (Anticipated)

April 1, 2009

Study Completion (Anticipated)

June 1, 2009

Study Registration Dates

First Submitted

April 14, 2008

First Submitted That Met QC Criteria

April 17, 2008

First Posted (Estimate)

April 18, 2008

Study Record Updates

Last Update Posted (Estimate)

January 29, 2009

Last Update Submitted That Met QC Criteria

January 28, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TGC-AP-03
  • 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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