Effect of an Artificial Pancreas in Patients Undergoing Pancreatic Resection

Overview

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

Full Title of Study: “Prevention for Surgical Site Infection After Pancreatic Resection”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2009

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.

Interventions

  • Device: the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)
    • artificial pancreas

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • the incidence of hypoglycemia and cost during the hospitalization
    • Time Frame: during the hospitalization

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kochi University
  • Provider of Information About this Clinical Study
    • Kochi University, Kochi Medical School
  • Overall Official(s)
    • Takehiro Okabayashi, MD, Study Director, Kochi Medical School
  • Overall Contact(s)
    • Takehiro Okabayashi, MD, 81-88-880-2370, tokabaya@kochi-u.ac.jp

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