Effect of an Artificial Pancreas in Patients Undergoing Pancreatic Resection
Information source: Kochi University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreatic Diseases
Intervention: the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan) (Device)
Phase: Phase 4
Status: Recruiting
Sponsored by: Kochi University Official(s) and/or principal investigator(s):
Takehiro Okabayashi, MD, Study Director, Affiliation: Kochi Medical School
Overall contact:
Takehiro Okabayashi, MD, Phone: 81-88-880-2370, Email: tokabaya@kochi-u.ac.jp
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.
Clinical Details
Official title: Prevention for Surgical Site Infection After Pancreatic Resection
Study design: Prevention, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: the incidence of surgical site infection
Secondary outcome: the incidence of hypoglycemia and cost during the hospitalization
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Takehiro Okabayashi, MD, Phone: 81-88-880-2370, Email: tokabaya@kochi-u.ac.jp
Kochi Medical School, Nankoku-City, Kochi 783-8505, Japan; Recruiting
Takehiro Okabayashi, MD, Phone: 81-88-880-2370, Email: tokabaya@kochi-u.ac.jp
Kazuhiro Hanazaki, Prof, Phone: 81-88-880-2370, Email: im31@kochi-u.ac.jp
Additional Information
Starting date: April 2007
Ending date: June 2009
Last updated: April 18, 2008
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