Effect of an Artificial Pancreas in Patients Undergoing Hepatic Resection

Kochi University

Status and phase: Completed; Phase 4

Conditions: Liver Diseases

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00659698

Kochi University

TGC-AP-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

1

Experimental group

Description:

received programmed infusions of insulin determined by the control algorithm of the artificial pancreas

Treatment:

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

2

No Intervention group

Description:

glucose levels were controlled using a manual injection of insulin according to the commonly used sliding scale