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Sponsored by: |
Kochi University |
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Information provided by: | Kochi University |
ClinicalTrials.gov Identifier: | NCT00661648 |
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 |
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Pancreatic Diseases |
Device: the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan) |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Prevention for Surgical Site Infection After Pancreatic Resection |
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 |
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1: No Intervention
glucose levels were controlled using sliding scale
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2: Experimental
received programmed infusions of insulin determined by the control algorithm of the artificial pancreas
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Device: the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)
artificial pancreas
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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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Japan, Kochi | |
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 |
Study Director: | Takehiro Okabayashi, MD | Kochi Medical School |
Responsible Party: | Kochi Medical School ( Kochi University ) |
Study ID Numbers: | TGC-AP-03, Kochi University |
Study First Received: | April 14, 2008 |
Last Updated: | April 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00661648 |
Health Authority: | Japan: Ministry of Education, Culture, Sports, Science and Technology |
surgery |
Digestive System Diseases Pancreatic Diseases Pancrelipase |
Therapeutic Uses Gastrointestinal Agents Pharmacologic Actions |