UMIN-CTR Clinical Trial

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
Email	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
Email	washi@med.toho-u.ac.jp

Sponsor
Institute	Toho University Omori Medical Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018466