UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015868 |
|---|---|
| Receipt number | R000018466 |
| Scientific Title | Clinical research of stress response inducing by enteral nutrition with naso-gastric catheter or gastrostoma |
| Date of disclosure of the study information | 2014/12/07 |
| Last modified on | 2021/06/12 11:19:40 |
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Basic information
Public title
Clinical research of stress response inducing by enteral nutrition with naso-gastric catheter or gastrostoma
Acronym
Stress response inducing by naso-gastric catheter or gastrostoma
Scientific Title
Clinical research of stress response inducing by enteral nutrition with naso-gastric catheter or gastrostoma
Scientific Title:Acronym
Stress response inducing by naso-gastric catheter or gastrostoma
Region
| Japan |
Condition
Condition
digestion or swallowing disturbance
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Oto-rhino-laryngology |
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is investigation of the stress associated with tube feeding as a reason to determine long-term tube feeding to select which method is better.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
serum CRP consentration, urin 8-OHdG, heart rate, body temparature
Key secondary outcomes
serum totak protein consentration, serum albumin consentration, serum cholesterol consentration, serum cholin esterase consentration, blodd cell counts, urin pH, body height, body weight, arm circumference, triscupid skinfold thicness
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with digestion or swallowing disturbance from 20 to 70 yeas old.
The patients who are planed the tube feeding for 3 weeks or longer.
The patients who undergo the tube feeding with naso-gastric catheter for 7days or lomger.
The patients who are planed percutaneous endoscopic gastrostomy.
Key exclusion criteria
The patients who is unsuitable as a subject of this investigation by physician judgment.
The patients who did not undergo percutaneous endoscopic gasrostomy.
The patients outside the indication for
tube feeding.
The patients who have complication.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Naohiro |
| Middle name | |
| Last name | Washizawa |
Organization
Toho University Omori Medical Center
Division name
Nutrition Therapy Center
Zip code
1438541
Address
Omori-Nishi 6-11-1, Ota-Ku, Tokyo, Japan
TEL
+81-3-3762-4151
washi@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Naohiro |
| Middle name | |
| Last name | Washizawa |
Organization
Nutrition Therapy Center
Division name
Nutrition Therapy Center
Zip code
1438541
Address
Omori-Nishi 6-11-1, Ota-Ku, Tokyo, Japan
TEL
0337624151
Homepage URL
https://www.lab.toho-u.ac.jp/med/omori/eiyo_chiryo/index.html
washi@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toho University Omori Medical Center
Address
Omori-Nishi6-11-1, Ota-Ku, Tokyo, Japan
Tel
0337624151
washi@med.toho-u.ac.jp
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
東邦大学医療センター大森病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 07 | 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
| Delay expected |
Results Delay Reason
Data analysis delay
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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
We pick the cbjects up from all patients who undergo the PEG, and ruleout the outside patients. there was no mistake of study because the all objects by investigator himself.
Management information
Registered date
| 2014 | Year | 12 | Month | 07 | Day |
Last modified on
| 2021 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018466
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
