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
Information provided by:
Kochi University
ClinicalTrials.gov Identifier:
First received: April 14, 2008
Last updated: January 28, 2009
Last verified: January 2009
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: 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.

Ages Eligible for Study:   Child, Adult, Senior
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00661648

Kochi Medical School
Nankoku-City, Kochi, Japan, 783-8505
Sponsors and Collaborators
Kochi University
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:

Additional relevant MeSH terms:
Pancreatic Diseases
Digestive System Diseases
Gastrointestinal Agents

ClinicalTrials.gov processed this record on January 19, 2017