Effect of an Artificial Pancreas in Patients Undergoing Pancreatic Resection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Kochi University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kochi University
ClinicalTrials.gov Identifier:
NCT00661648
First received: April 14, 2008
Last updated: January 28, 2009
Last verified: January 2009
  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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • the incidence of hypoglycemia and cost during the hospitalization [ Time Frame: during the hospitalization ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Kochi University:
surgery

Additional relevant MeSH terms:
Pancreatic Diseases
Digestive System Diseases
Pancreatin
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014