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Effect of an Artificial Pancreas in Patients Undergoing Pancreatic Resection
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by Kochi University.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Kochi University
Information provided by:
Kochi University
ClinicalTrials.gov Identifier:
NCT00661648
First received: April 14, 2008
Last updated: January 28, 2009
Last verified: January 2009
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Purpose
This study evaluated that strict control of perioperative blood glucose following pancreatic resection by using an artificial pancreas would improve postoperative surgical site infection.
| Condition | Intervention | Phase |
|---|---|---|
| Pancreatic Diseases | Device: the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan) | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention |
| Official Title: | Prevention for Surgical Site Infection After Pancreatic Resection |
Resource links provided by NLM:
Further study details as provided by Kochi University:
Primary Outcome Measures:
- the incidence of surgical site infection [ Time Frame: 30th postoperative day ]
Secondary Outcome Measures:
- the incidence of hypoglycemia and cost during the hospitalization [ Time Frame: during the hospitalization ]
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Device: the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)
artificial pancreas
Other Name: an artificial pancreas system (Nikkiso Inc, Tokyo, Japan)
|
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| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00661648
Please refer to this study by its ClinicalTrials.gov identifier: NCT00661648
Contacts
| Contact: Takehiro Okabayashi, MD | 81-88-880-2370 | tokabaya@kochi-u.ac.jp | |
| Contact: Kazuhiro Hanazaki, Prof | 81-88-880-2370 | im31@kochi-u.ac.jp |
Locations
| Japan | |
| Kochi Medical School | Recruiting |
| Nankoku-City, Kochi, Japan, 783-8505 | |
| Contact: Takehiro Okabayashi, MD 81-88-880-2370 tokabaya@kochi-u.ac.jp | |
| Contact: Kazuhiro Hanazaki, Prof 81-88-880-2370 im31@kochi-u.ac.jp | |
Sponsors and Collaborators
Kochi University
Investigators
| Study Director: | Takehiro Okabayashi, MD | Kochi Medical School |
More Information
| Responsible Party: | Kochi University, Kochi Medical School |
| ClinicalTrials.gov Identifier: | NCT00661648 History of Changes |
| Other Study ID Numbers: |
TGC-AP-03 Kochi University |
| Study First Received: | April 14, 2008 |
| Last Updated: | January 28, 2009 |
Keywords provided by Kochi University:
|
surgery |
Additional relevant MeSH terms:
|
Pancreatic Diseases Digestive System Diseases Pancrelipase Pancreatin Gastrointestinal Agents |
ClinicalTrials.gov processed this record on August 18, 2017