Effect of an Artificial Pancreas in Patients Undergoing Hepatic Resection

Phase 4

Completed

• Conditions: Liver Diseases
• Interventions: Device: the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)

• Registration Number: NCT00659698
• Lead Sponsor: Kochi University

Brief Summary

This study evaluated that strict control of perioperative blood glucose following hepatic resection by using an artificial pancreas would improve postoperative surgical site infection.

Detailed Description

This study recruited 70 patients undergoing elective hepatic resection for liver diseases. Perioperative blood glucose concentration was continuously monitored using an artificial pancreas system. We prospectively divided patients 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 infusions of insulin determined by the control algorithm of the artificial pancreas.

Study Timeline

• Study Start: 2007-04
• Status Verified: 2008-04
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Study First Submitted: 2008-04-11
• Study First Submitted QC: 2008-04-15
• Last Update Submitted: 2008-04-15
• Study First Posted: 2008-04-16
• Last Update Posted: 2008-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• This study recruited 70 patients undergoing elective hepatic resection for liver diseases. Perioperative blood glucose concentration was continuously monitored using an artificial pancreas system.

Exclusion Criteria

• weight loss greater than 10% during the previous 6 months, signs of distant metastasis, and respiratory, renal, or heart disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)	received programmed infusions of insulin determined by the control algorithm of the artificial pancreas

Primary Outcome Measures

Name	Time	Method
the incidence of surgical site infection	30th postoperative day

Secondary Outcome Measures

Name	Time	Method
the incidence of hypoglycemia and cost during the hospitalization	during the hospitalization

Trial Locations

Locations (1)

Kochi Medical School; 🇯🇵 Nankoku-City, Kochi, Japan