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Effect of an Artificial Pancreas in Patients Undergoing Pancreatic Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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, Older Adult
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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


Contacts
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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
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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
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Study Director: Takehiro Okabayashi, MD Kochi Medical School
More Information
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Responsible Party: Kochi University, Kochi Medical School
ClinicalTrials.gov Identifier: NCT00661648    
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:
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Pancreatic Diseases
Digestive System Diseases
Pancrelipase
Gastrointestinal Agents