Official Title: “Continuous Postoperative Blood Glucose Monitoring and Control by an Artificial Pancreas in Patients Undergoing Pancreatic Resection: A Prospective Randomized Clinical Trial”

This study evaluated a closed-loop system providing continuous monitoring and strict control of perioperative blood glucose following pancreatic resection.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2007

This study recruited 32 patients undergoing elective pancreatic resection for pancreatic disease.

Intervention(s) in this Clinical Trial

• Device: Artificial Pancreas (STG-22)
  • safe tool

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 2
  • Thirty patients who underwent pancreatic resection for pancreatic neoplasm were prospectively randomized. Perioperative blood glucose levels were continuously monitored using an artificial endocrine pancreas (STG-22). Glucose levels were controlled using either the sliding scale method or the artificial pancreas.

Primary Measures

• the incidence of severe hypoglycemia (< 40 mg/dl) during the intensive care period following pancreatic resection in patients monitored using the artificial pancreas
  • Time Frame: the first postoperative 18 hours in the surgical intensive care unit
    Safety Issue?: Yes

Secondary Measures

• the total amount of insulin required for glycemic control after pancreatic resection
  • Time Frame: the first postoperative 18 hours in the surgical intensive care unit
    Safety Issue?: Yes

Inclusion Criteria:

• This study recruited 32 patients undergoing elective pancreatic resection for pancreatic disease.

Exclusion Criteria:

• weight loss greater than 10% during the previous 6 months
• signs of distant metastasis
• respiratory, renal,or heart disease
• Patients provided written informed consent prior to enrollment

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

Lead Sponsor: Kochi University

Overall Clinical Trial Officials and Contacts

Takehiro Okabayashi, MD Study Director Kochi Medical School, Kochi University  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00657995

Study ID Number: TGC-AP-01

ClinicalTrials.gov Identifier: NCT00657995

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