Effect of an Artificial Pancreas in Patients Undergoing Pancreatic Resection

NCT ID: NCT00661648

Last Updated: 2009-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Pancreatic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

glucose levels were controlled using sliding scale

Group Type NO_INTERVENTION

No interventions assigned to this group

2

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

artificial pancreas

Interventions

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

artificial pancreas

Intervention Type DEVICE

Other Intervention Names

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an artificial pancreas system (Nikkiso Inc, Tokyo, Japan)

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kochi University

OTHER

Sponsor Role lead

Responsible Party

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Kochi Medical School

Principal Investigators

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Takehiro Okabayashi, MD

Role: STUDY_DIRECTOR

Kochi Medical School

Locations

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Kochi Medical School

Nankoku, Kochi, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Takehiro Okabayashi, MD

Role: CONTACT

81-88-880-2370

Kazuhiro Hanazaki, Prof

Role: CONTACT

81-88-880-2370

Facility Contacts

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Takehiro Okabayashi, MD

Role: primary

81-88-880-2370

Kazuhiro Hanazaki, Prof

Role: backup

81-88-880-2370

Other Identifiers

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Kochi University

Identifier Type: -

Identifier Source: secondary_id

TGC-AP-03

Identifier Type: -

Identifier Source: org_study_id

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