Effect of an Artificial Pancreas in Patients Undergoing Pancreatic Resection

Pancreatic Diseases Clinical Trial

Official title:

Prevention for Surgical Site Infection After Pancreatic Resection

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00661648
• Other study ID #: TGC-AP-03
• Secondary ID: Kochi University
• Status: Unknown status
• Phase: Phase 4
• First received: April 14, 2008
• Last updated: January 28, 2009
• Start date: April 2007
• Est. completion date: June 2009

Study information

• Verified date: January 2009
• Source: Kochi University
• Contact: Takehiro Okabayashi, MD
• Phone: 81-88-880-2370
• Email: tokabaya[@]kochi-u.ac.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 50
• Est. completion date: June 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Diseases

Intervention

Device:
• the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)
artificial pancreas

Locations

Country	Name	City	State
Japan	Kochi Medical School	Nankoku-City	Kochi

Sponsors (1)

Lead Sponsor	Collaborator
Kochi University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of surgical site infection		30th postoperative day
Secondary	the incidence of hypoglycemia and cost during the hospitalization		during the hospitalization