Liver DiseasesPhase 4NCT00659698
Effect of an Artificial Pancreas in Patients Undergoing Hepatic Resection
A Phase 4 study testing the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan) in people with Liver Diseases, run by Kochi University at 1 site in Japan.
Trial summary
This study evaluated that strict control of perioperative blood glucose following hepatic 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
- Liver 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
- 70 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2007to Apr 2008
- 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
- This study recruited 70 patients undergoing elective hepatic resection for liver diseases. Perioperative blood glucose concentration was continuously monitored using an artificial pancreas system.
Who cannot join
- weight loss greater than 10% during the previous 6 months, signs of distant metastasis, and respiratory, renal, or heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention for Surgical Site Infection After Hepatic Resection
This study evaluated that strict control of perioperative blood glucose following hepatic resection by using an artificial pancreas would improve postoperative surgical site infection.
Read the detailed description
This study recruited 70 patients undergoing elective hepatic resection for liver diseases. Perioperative blood glucose concentration was continuously monitored using an artificial pancreas system. We prospectively divided patients 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 infusions of insulin determined by the control algorithm of the artificial pancreas.
- Conditions
- Liver Diseases
- Being tested
- the closed-loop STG-22 system (Nikkiso Inc, Tokyo, Japan)
- Keywords
- surgical, site, infection
- Medical subject headings
- Liver Diseases, Infections
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 | 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) |
| 2 | No intervention | glucose levels were controlled using a manual injection of insulin according to the commonly used sliding scale |
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 posted16 Apr 2008 (estimated)
- Study startApr 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver 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
- 70 participants (actual)
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
- NCT00659698
- Sponsor's protocol ID
- TGC-AP-02
- Other IDs
- Kochi University
- Status last verified
- Apr 2008
- First submitted
- 11 Apr 2008
- Last updated
- 16 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention for Surgical Site Infection After Hepatic Resection
- ClinicalTrials.gov ID
- NCT00659698
- Acronym / sponsor ID
- TGC-AP-02
- Conditions
- Liver Diseases
- Keywords
- surgical, site, infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kochi UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 16 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 hepatic resection by using an artificial pancreas would improve postoperative surgical site infection.
Detailed description
This study recruited 70 patients undergoing elective hepatic resection for liver diseases. Perioperative blood glucose concentration was continuously monitored using an artificial pancreas system. We prospectively divided patients 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 infusions 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 | 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 |
| 2 | No intervention | –glucose levels were controlled using a manual injection of insulin according to the commonly used sliding scale |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- This study recruited 70 patients undergoing elective hepatic resection for liver diseases. Perioperative blood glucose concentration was continuously monitored using an artificial pancreas system.
Key exclusion criteria (1 listed)
- weight loss greater than 10% during the previous 6 months, signs of distant metastasis, and 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 | 1 |
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2008.
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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 Liver 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 1 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: finished, as of the sponsor's last update on 16 Apr 2008. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 16 Apr 2008.