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Effect of an Artificial Pancreas in Patients Undergoing Hepatic Resection

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ClinicalTrials.gov Identifier: NCT00659698
Recruitment Status : Completed
First Posted : April 16, 2008
Last Update Posted : April 16, 2008
Sponsor:
Information provided by:
Kochi University

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

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention for Surgical Site Infection After Hepatic Resection
Study Start Date : April 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine


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 Name: 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



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 ]


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

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

Information from the National Library of Medicine

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): NCT00659698


Locations
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Japan
Kochi Medical School
Nankoku-City, Kochi, Japan, 783-8505
Sponsors and Collaborators
Kochi University
Investigators
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Study Director: Takehiro Okabayashi, MD Kochi Medical School

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Responsible Party: Kochi University, Kochi Medical School
ClinicalTrials.gov Identifier: NCT00659698     History of Changes
Other Study ID Numbers: TGC-AP-02
Kochi University
First Posted: April 16, 2008    Key Record Dates
Last Update Posted: April 16, 2008
Last Verified: April 2008
Keywords provided by Kochi University:
surgical
site
infection
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents