Effect of an Artificial Pancreas in Patients Undergoing Pancreatic Resection

Kochi University

Status and phase: Unknown; Phase 4

Conditions: Pancreatic Diseases

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00661648

TGC-AP-03

Kochi University

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

1

No Intervention group

Description:

glucose levels were controlled using sliding scale

2

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)