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Effect of an Artificial Pancreas in Patients Undergoing Pancreatic Resection

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ClinicalTrials.gov Identifier: NCT00661648
Recruitment Status : Unknown
Verified January 2009 by Kochi University.
Recruitment status was:  Recruiting
First Posted : April 18, 2008
Last Update Posted : January 29, 2009
Sponsor:
Information provided by:
Kochi University

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

Condition or disease Intervention/treatment Phase
Pancreatic Diseases Device: the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan) Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention for Surgical Site Infection After Pancreatic Resection
Study Start Date : April 2007
Estimated Primary Completion Date : April 2009
Estimated Study Completion Date : June 2009

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Arms and Interventions
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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 Name: an artificial pancreas system (Nikkiso Inc, Tokyo, Japan)


Outcome Measures
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Primary Outcome Measures :
  1. the incidence of surgical site infection [ Time Frame: 30th postoperative day ]

Secondary Outcome Measures :
  1. the incidence of hypoglycemia and cost during the hospitalization [ Time Frame: during the hospitalization ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00661648


Contacts
Contact: Takehiro Okabayashi, MD 81-88-880-2370 tokabaya@kochi-u.ac.jp
Contact: Kazuhiro Hanazaki, Prof 81-88-880-2370 im31@kochi-u.ac.jp

Locations
Japan
Kochi Medical School Recruiting
Nankoku-City, Kochi, Japan, 783-8505
Contact: Takehiro Okabayashi, MD    81-88-880-2370    tokabaya@kochi-u.ac.jp   
Contact: Kazuhiro Hanazaki, Prof    81-88-880-2370    im31@kochi-u.ac.jp   
Sponsors and Collaborators
Kochi University
Investigators
Study Director: Takehiro Okabayashi, MD Kochi Medical School
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Kochi University, Kochi Medical School
ClinicalTrials.gov Identifier: NCT00661648     History of Changes
Other Study ID Numbers: TGC-AP-03
Kochi University
First Posted: April 18, 2008    Key Record Dates
Last Update Posted: January 29, 2009
Last Verified: January 2009

Keywords provided by Kochi University:
surgery

Additional relevant MeSH terms:
Pancreatic Diseases
Digestive System Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents