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Effect of an Artificial Pancreas in Patients Undergoing Pancreatic Resection

Prevention for Surgical Site Infection After Pancreatic Resection

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00661648
Enrollment
50
Registered
2008-04-18
Start date
2007-04-30
Completion date
2009-06-30
Last updated
2009-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Diseases

Keywords

surgery

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.

Interventions

Sponsors

Kochi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frame
the incidence of surgical site infection30th postoperative day

Secondary

MeasureTime frame
the incidence of hypoglycemia and cost during the hospitalizationduring the hospitalization

Countries

Japan

Contacts

Primary ContactTakehiro Okabayashi, MD
tokabaya@kochi-u.ac.jp81-88-880-2370
Backup ContactKazuhiro Hanazaki, Prof
im31@kochi-u.ac.jp81-88-880-2370

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026