NCT00661648

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 14, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 18, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

January 29, 2009

Status Verified

January 1, 2009

Enrollment Period

2 years

First QC Date

April 14, 2008

Last Update Submit

January 28, 2009

Conditions

Pancreatic Diseases

Keywords

surgery

Outcome Measures

Primary Outcomes (1)

  • the incidence of surgical site infection

    30th postoperative day

Secondary Outcomes (1)

  • the incidence of hypoglycemia and cost during the hospitalization

    during the hospitalization

Study Arms (2)

1

NO INTERVENTION

glucose levels were controlled using sliding scale

2

EXPERIMENTAL

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

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

Interventions

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

artificial pancreas

Also known as: an artificial pancreas system (Nikkiso Inc, Tokyo, Japan)
2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing elective pancreatic resection for pancreatic diseases.

You may not qualify if:

  • weight loss greater than 10% during the previous 6 months
  • sign of distant metastasis
  • respiratory, renal, or heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kochi Medical School

Nankoku, Kochi, 783-8505, Japan

RECRUITING

MeSH Terms

Conditions

Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Takehiro Okabayashi, MD

    Kochi Medical School

    STUDY DIRECTOR

Central Study Contacts

Takehiro Okabayashi, MD

CONTACT

81-88-880-2370tokabaya@kochi-u.ac.jp

Kazuhiro Hanazaki, Prof

CONTACT

81-88-880-2370im31@kochi-u.ac.jp

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 14, 2008

First Posted

April 18, 2008

Study Start

April 1, 2007

Primary Completion

April 1, 2009

Study Completion

June 1, 2009

Last Updated

January 29, 2009

Record last verified: 2009-01

Locations

JP(1)