Effect of an Artificial Pancreas in Patients Undergoing Hepatic Resection

Condition(s) targeted: Liver Diseases

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

Phase: Phase 4

Status: Completed

Sponsored by: Kochi University

Official(s) and/or principal investigator(s):
Takehiro Okabayashi, MD, Study Director, Affiliation: Kochi Medical School

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

Official title: Prevention for Surgical Site Infection After Hepatic Resection

Study design: Prevention, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: the incidence of surgical site infection

Secondary outcome: the incidence of hypoglycemia and cost during the hospitalization

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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Kochi Medical School, Nankoku-City, Kochi 783-8505, Japan

Starting date: April 2007
Ending date: April 2008
Last updated: April 15, 2008