Pancreatic DiseasesPhase 4NCT00661648
Effect of an Artificial Pancreas in Patients Undergoing Pancreatic Resection
A Phase 4 study testing the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan) in people with Pancreatic Diseases, run by Kochi University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Diseases
- What is being tested?
- the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2007to Jun 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients undergoing elective pancreatic resection for pancreatic diseases.
Who cannot join
- weight loss greater than 10% during the previous 6 months
- sign of distant metastasis
- respiratory, renal, or heart disease
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Kochi Medical School
Nankoku, Kochi, 783-8505
Takehiro Okabayashi, MD, 81-88-880-2370, tokabaya@kochi-u.ac.jp
Kazuhiro Hanazaki, Prof, 81-88-880-2370, im31@kochi-u.ac.jp
About this study
Official title: Prevention for Surgical Site Infection After Pancreatic Resection
This study evaluated that strict control of perioperative blood glucose following pancreatic resection by using an artificial pancreas would improve postoperative surgical site infection.
Read the 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.
- Conditions
- Pancreatic Diseases
- Being tested
- the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)
- Keywords
- surgery
- Medical subject headings
- Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)Device
Also called an artificial pancreas system (Nikkiso Inc, Tokyo, Japan)
artificial pancreas
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of surgical site infection
Measured: 30th postoperative day
Secondary outcomes (1)
the incidence of hypoglycemia and cost during the hospitalization
Measured: during the hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startApr 2007
- Primary completionApr 2009 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kochi University
- Sponsor type
- University, hospital or other
- Investigators
- Takehiro Okabayashi, MD, Study director, Kochi Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661648
- Sponsor's protocol ID
- TGC-AP-03
- Other IDs
- Kochi University
- Status last verified
- Jan 2009
- First submitted
- 14 Apr 2008
- Last updated
- 29 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention for Surgical Site Infection After Pancreatic Resection
- ClinicalTrials.gov ID
- NCT00661648
- Acronym / sponsor ID
- TGC-AP-03
- Conditions
- Pancreatic Diseases
- Keywords
- surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kochi UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Apr 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 18 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –glucose levels were controlled using sliding scale |
| 2 | Experimental | Device: the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)received programmed infusions of insulin determined by the control algorithm of the artificial pancreas |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing elective pancreatic resection for pancreatic diseases.
Key exclusion criteria (3 listed)
- weight loss greater than 10% during the previous 6 months
- sign of distant metastasis
- respiratory, renal, or heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)Also: an artificial pancreas system (Nikkiso Inc, Tokyo, Japan)artificial pancreas | Device | 2 |
Primary outcome
the incidence of surgical site infection
Time frame: 30th postoperative day
1 secondary outcome
the incidence of hypoglycemia and cost during the hospitalization
Time frame: during the hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takehiro Okabayashi, MD study director
Kochi Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan) in people with Pancreatic Diseases, run by Kochi University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Takehiro Okabayashi, MD (81-88-880-2370, tokabaya@kochi-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of surgical site infection (time frame: 30th postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2009.