Effect of an Artificial Pancreas in Patients Undergoing Pancreatic Resection
Phase 4
- Conditions
- Pancreatic Diseases
- Interventions
- Device: the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)
- Registration Number
- NCT00661648
- Lead Sponsor
- Kochi University
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 2 the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan) received programmed infusions of insulin determined by the control algorithm of the artificial pancreas
- Primary Outcome Measures
Name Time Method the incidence of surgical site infection 30th postoperative day
- Secondary Outcome Measures
Name Time Method the incidence of hypoglycemia and cost during the hospitalization during the hospitalization
Trial Locations
- Locations (1)
Kochi Medical School
🇯🇵Nankoku-City, Kochi, Japan