UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035383 |
|---|---|
| Receipt number | R000040318 |
| Scientific Title | Study of Blood Collection Catheter for Blood Glucose Management with Artificial Pancreas after Esophageal Surgery |
| Date of disclosure of the study information | 2019/01/31 |
| Last modified on | 2018/12/27 18:08:50 |
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Basic information
Public title
Study of Blood Collection Catheter for Blood Glucose Management with Artificial Pancreas after Esophageal Surgery
Acronym
Catheter of artificial pancreas after esophagectomy
Scientific Title
Study of Blood Collection Catheter for Blood Glucose Management with Artificial Pancreas after Esophageal Surgery
Scientific Title:Acronym
Catheter of artificial pancreas after esophagectomy
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To find optimum catheter for blood glucose control with artificial pancreas
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of defective blood sampling
Key secondary outcomes
Problem solving method required when blood sampling failure.
Time taken to recover from blood sampling failure.
Percentage of blood sampling failures time during use of artificial pancreas .
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A group, intravenous indwelling catheters (Insight, 20 G, 30 mm) manufactured by Becton Dickinson Company
Interventions/Control_2
B group, intravenous indwelling catheter (Insight, 22 G, 32 mm) manufactured by Japan Becton Dickinson and Company
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Among patients who underwent esophageal resection, cases in which blood glucose control is performed.
2. A performance status of 0-2 accord
ing to the Eastern Cooperative Oncol
ogy Group (ECOG) scale.
3. An age of 20 years and over.
4. Patients who are considered to survive for more than 3 months from the registration.
5. Vital organ functions are preserved within 14 days prior to entry.
6. Sufficient oral intake.
7. All patients gave written informed
consent.
Key exclusion criteria
1. Obvious infection or inflammation.
2. Serious cardiovascular diseases.
3. Serious concurrent disease such as intestinal palsy, small bowel obstraction, uncontrolable diabetes mellitus, renal failure, liver cirrhosis, and so on.
4. Massive ascites beyond the pelvic cavity or pleural effusion.
5. Women who are pregnant or hope to become pregnant during the study period. Men who wish their partner to become pregnant.
6. Patients judged inappropriate for the study by their physicians.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Kitagawa |
Organization
Kochi Medical School
Division name
Department of Surgery
Zip code
Address
Kohasu, Okocho, nankoku, Kochi, 783-8505
TEL
088-880-2371
kitagawah@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Kitagawa |
Organization
Kochi Medical School
Division name
Department of Surgery
Zip code
Address
Kohasu, Okocho, nankoku, Kochi, 783-8505
TEL
088-880-2371
Homepage URL
kitagawah@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2018 | Year | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 01 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 27 | Day |
Last modified on
| 2018 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040318
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
