Effect of an Artificial Pancreas in Patients Undergoing Pancreatic Resection

Verified by: Kochi University, January 2009
First Received: April 14, 2008 | Last Updated: January 28, 2009 | Phase: Phase 4 | Start Date: April 2007
Overall Status: Recruiting | Estimated Enrollment: 50
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This study evaluated that strict control of perioperative blood glucose following pancreatic resection by using an artificial pancreas would improve postoperative surgical site infection...

Brief Summary

Official Title: “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 Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
  • Study Primary Completion Date: April 2009

Detailed Clinical Trial 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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

  • 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

Outcome Measures for this Clinical Trial

Primary Measures

  • the incidence of surgical site infection
    • Time Frame: 30th postoperative day
      Safety Issue?: Yes

Secondary Measures

  • the incidence of hypoglycemia and cost during the hospitalization
    • Time Frame: during the hospitalization
      Safety Issue?: Yes

Criteria for Participation 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 for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Kochi University Other

Overall Clinical Trial Officials and Contacts

Takehiro Okabayashi, MD Study Director Kochi Medical School  

Overall Contact: Takehiro Okabayashi, MD 81-88-880-2370 tokabaya@kochi-u.ac.jp

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00661648

Study ID Number: TGC-AP-03

ClinicalTrials.gov Identifier: NCT00661648

Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology

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