Pancreatic NeoplasmNCT00657995
Tight Glycemic Control by Artificial Pancreas
A study testing Artificial Pancreas (STG-22) in people with Pancreatic Neoplasm, run by Kochi University at 1 site in Japan.
Trial summary
This study evaluated a closed-loop system providing continuous monitoring and strict control of perioperative blood glucose following pancreatic resection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Neoplasm
- What is being tested?
- Artificial Pancreas (STG-22)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2007to Dec 2007
- Phase
- Interventional
- 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 32 patients undergoing elective pancreatic resection for pancreatic disease.
Who cannot join
- weight loss greater than 10% during the previous 6 months
- signs of distant metastasis
- respiratory, renal,or heart disease
- Patients provided written informed consent prior to enrollment
Trial locations and contacts
1 site in 1 country.
Japan1 site
Kochi Medical School, Kochi University
Nankoku, Kohasu-Okocho, 783-8505
About this study
Official title: Continuous Postoperative Blood Glucose Monitoring and Control by an Artificial Pancreas in Patients Undergoing Pancreatic Resection: A Prospective Randomized Clinical Trial
This study evaluated a closed-loop system providing continuous monitoring and strict control of perioperative blood glucose following pancreatic resection.
Read the detailed description
This study recruited 32 patients undergoing elective pancreatic resection for pancreatic disease.
- Conditions
- Pancreatic Neoplasm
- Being tested
- Artificial Pancreas (STG-22)
- Keywords
- pancreatogenic, diabetes, artificial, pancreas
- Medical subject headings
- Pancreatic Neoplasms, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Pancreas (STG-22)Device
Also called STG-22; NIKKISO Corporation, Japan
safe tool
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Thirty patients who underwent pancreatic resection for pancreatic neoplasm were prospectively randomized. Perioperative blood glucose levels were continuously monitored using an artificial endocrine pancreas (STG-22). Glucose levels were controlled using either the sliding scale method or the artificial pancreas. Receives: Device: Artificial Pancreas (STG-22) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of severe hypoglycemia (< 40 mg/dl) during the intensive care period following pancreatic resection in patients monitored using the artificial pancreas
Measured: the first postoperative 18 hours in the surgical intensive care unit
Secondary outcomes (1)
the total amount of insulin required for glycemic control after pancreatic resection
Measured: the first postoperative 18 hours in the surgical intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startApr 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kochi University
- Sponsor type
- University, hospital or other
- Investigators
- Takehiro Okabayashi, MD, Study director, Kochi Medical School, Kochi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657995
- Sponsor's protocol ID
- TGC-AP-01
- Status last verified
- Apr 2008
- First submitted
- 4 Apr 2008
- Last updated
- 14 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Postoperative Blood Glucose Monitoring and Control by an Artificial Pancreas in Patients Undergoing Pancreatic Resection: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00657995
- Acronym / sponsor ID
- TGC-AP-01
- Conditions
- Pancreatic Neoplasm
- Keywords
- pancreatogenic, diabetes, artificial, pancreas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Kochi UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 14 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 a closed-loop system providing continuous monitoring and strict control of perioperative blood glucose following pancreatic resection.
Detailed description
This study recruited 32 patients undergoing elective pancreatic resection for pancreatic disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Device: Artificial Pancreas (STG-22)Thirty patients who underwent pancreatic resection for pancreatic neoplasm were prospectively randomized. Perioperative blood glucose levels were continuously monitored using an artificial endocrine pancreas (STG-22). Glucose levels were controlled using either the sliding scale method or the artificial pancreas. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- This study recruited 32 patients undergoing elective pancreatic resection for pancreatic disease.
Key exclusion criteria (4 listed)
- weight loss greater than 10% during the previous 6 months
- signs of distant metastasis
- respiratory, renal,or heart disease
- Patients provided written informed consent prior to enrollment
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 |
|---|---|---|
| Artificial Pancreas (STG-22)Also: STG-22; NIKKISO Corporation, Japansafe tool | Device | 2 |
Primary outcome
the incidence of severe hypoglycemia (< 40 mg/dl) during the intensive care period following pancreatic resection in patients monitored using the artificial pancreas
Time frame: the first postoperative 18 hours in the surgical intensive care unit
1 secondary outcome
the total amount of insulin required for glycemic control after pancreatic resection
Time frame: the first postoperative 18 hours in the surgical intensive care unit
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 14 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, Kochi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Pancreas (STG-22) in people with Pancreatic Neoplasm, 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 4 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 14 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.
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 severe hypoglycemia (< 40 mg/dl) during the intensive care period following pancreatic resection in patients monitored using the artificial pancreas (time frame: the first postoperative 18 hours in the surgical intensive care unit). 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 14 Apr 2008.