Effect of an Artificial Pancreas in Patients Undergoing Pancreatic Resection - Full Text View

Sponsor:	Kochi University
Information provided by:	Kochi University
ClinicalTrials.gov Identifier:	NCT00661648

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 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

Resource links provided by NLM:

MedlinePlus related topics: Pancreatic Diseases Surgery

Drug Information available for: Pancrelipase Ultrase

U.S. FDA Resources

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
1: No Intervention glucose levels were controlled using sliding scale
2: Experimental 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

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

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
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 Medical School ( Kochi University )
Study ID Numbers:	TGC-AP-03, Kochi University
Study First Received:	April 14, 2008
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00661648 History of Changes
Health Authority:	Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Kochi University:

surgery

Additional relevant MeSH terms:

Digestive System Diseases
Therapeutic Uses
Gastrointestinal Agents

Pancreatic Diseases
Pancrelipase
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010