Effect of an Artificial Pancreas in Patients Undergoing P... | NCT00661648

Studies
Effect of an Artificial Pancreas in Patients Undergoing Pancreatic Resection

NCT00661648

Sponsor

Kochi University

Status

Unknown status

Last Update Posted

Jan 29, 2009Estimated

Enrollment

50Estimated

Phase

Phase 4

Conditions

Pancreatic Diseases

Interventions

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

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Kochi University

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Apr 2009Estimated

Completion Date

Jun 2009Estimated

First Submitted Date

Apr 14, 2008

First Submission Date that Met QC Criteria

Apr 17, 2008

First Posted Date

Apr 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2009

Last Update Posted Date

Jan 29, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)	Device	artificial pancreas	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the incidence of surgical site infection		30th postoperative day

Secondary Outcomes

Measure	Description	Time Frame
the incidence of hypoglycemia and cost during the hospitalization		during the hospitalization

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Takehiro Okabayashi, MD	Contact	81-88-880-2370		tokabaya@kochi-u.ac.jp
Kazuhiro Hanazaki, Prof	Contact	81-88-880-2370		im31@kochi-u.ac.jp

Overall Officials

Name	Affiliation	Role
Takehiro Okabayashi, MD	Kochi Medical School	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kochi Medical School	Recruiting	Nankoku	Kochi	783-8505	Japan

Type	Date	Date Unknown
Release	May 19, 2009
Reset	Jul 9, 2009
Release	Jul 13, 2009
Reset	Aug 19, 2009

Submission Tracking

Estimated Results First Submitted Date

May 19, 2009

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 19, 2009			Jul 9, 2009
Jul 13, 2009

Condition Browse Module

MeSH Terms

ID	Term
D010182	Pancreatic Diseases

Ancestor Terms

ID	Term
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided