Effect of an Artificial Pancreas in Patients Undergoing Pancreatic Resection
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ClinicalTrials.gov Identifier: NCT00661648 |
Recruitment Status : Unknown
Verified January 2009 by Kochi University.
Recruitment status was: Recruiting
First Posted : April 18, 2008
Last Update Posted : January 29, 2009
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Condition or disease | Intervention/treatment | Phase |
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Pancreatic Diseases | Device: the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Prevention for Surgical Site Infection After Pancreatic Resection |
Study Start Date : | April 2007 |
Estimated Primary Completion Date : | April 2009 |
Estimated Study Completion Date : | June 2009 |

Arm | Intervention/treatment |
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No Intervention: 1
glucose levels were controlled using sliding scale
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Experimental: 2
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
Other Name: an artificial pancreas system (Nikkiso Inc, Tokyo, Japan) |
- the incidence of surgical site infection [ Time Frame: 30th postoperative day ]
- the incidence of hypoglycemia and cost during the hospitalization [ Time Frame: during the hospitalization ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00661648
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 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 University, Kochi Medical School |
ClinicalTrials.gov Identifier: | NCT00661648 |
Other Study ID Numbers: |
TGC-AP-03 Kochi University |
First Posted: | April 18, 2008 Key Record Dates |
Last Update Posted: | January 29, 2009 |
Last Verified: | January 2009 |
surgery |
Pancreatic Diseases Digestive System Diseases Pancrelipase Gastrointestinal Agents |