Effect of an Artificial Pancreas in Patients Undergoing Pancreatic Resection

K

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)

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)

Trial contacts and locations

1

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Central trial contact

Kazuhiro Hanazaki, Prof; Takehiro Okabayashi, MD

Data sourced from clinicaltrials.gov

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