Back to resultsEffect of an Artificial Pancreas in Patients Undergoing Pancreatic Resection
Primary Purpose
Pancreatic Diseases
Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)
Sponsored by
About this trial
This is an interventional prevention trial for Pancreatic Diseases focused on measuring surgery
Eligibility 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
Sites / Locations
- Kochi Medical SchoolRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
1
2
Arm Description
glucose levels were controlled using sliding scale
received programmed infusions of insulin determined by the control algorithm of the artificial pancreas
Outcomes
Primary Outcome Measures
the incidence of surgical site infection
Secondary Outcome Measures
the incidence of hypoglycemia and cost during the hospitalization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00661648
Brief Title
Effect of an Artificial Pancreas in Patients Undergoing Pancreatic Resection
Official Title
Prevention for Surgical Site Infection After Pancreatic Resection
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
April 2009 (Anticipated)
Study Completion Date
June 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Kochi University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Diseases
Keywords
surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
glucose levels were controlled using sliding scale
Arm Title
2
Arm Type
Experimental
Arm Description
received programmed infusions of insulin determined by the control algorithm of the artificial pancreas
Intervention Type
Device
Intervention Name(s)
the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)
Other Intervention Name(s)
an artificial pancreas system (Nikkiso Inc, Tokyo, Japan)
Intervention Description
artificial pancreas
Primary Outcome Measure Information:
Title
the incidence of surgical site infection
Time Frame
30th postoperative day
Secondary Outcome Measure Information:
Title
the incidence of hypoglycemia and cost during the hospitalization
Time Frame
during the hospitalization
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Takehiro Okabayashi, MD
Phone
81-88-880-2370
Email
tokabaya@kochi-u.ac.jp
First Name & Middle Initial & Last Name or Official Title & Degree
Kazuhiro Hanazaki, Prof
Phone
81-88-880-2370
Email
im31@kochi-u.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takehiro Okabayashi, MD
Organizational Affiliation
Kochi Medical School
Official's Role
Study Director
Facility Information:
Facility Name
Kochi Medical School
City
Nankoku-City
State/Province
Kochi
ZIP/Postal Code
783-8505
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takehiro Okabayashi, MD
Phone
81-88-880-2370
Email
tokabaya@kochi-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Kazuhiro Hanazaki, Prof
Phone
81-88-880-2370
Email
im31@kochi-u.ac.jp
12. IPD Sharing Statement
Learn more about this trial
Effect of an Artificial Pancreas in Patients Undergoing Pancreatic Resection
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