UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study for prognosis factors of intestinal failure
Title of the study (Brief title)	Study for intestinal failure
Region	Japan

Condition
Condition	intestinal failure
Classification by specialty	Gastroenterology Gastrointestinal surgery Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	study of intestinal failure
Basic objectives2	Others
Basic objectives -Others	indication for intestinal transplant
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Survival
Key secondary outcomes

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	0 years-old <=
Age-upper limit	99 years-old >=
Gender	Male and Female
Key inclusion criteria	Intestinal failure with PN over 6 months
Key exclusion criteria	Intestinal failure caused by other organ origin
Target sample size	100

Research contact person
Name of lead principal investigator	Hiroomi Okuyama
Organization	Osaka University Graduate School of Medicine
Division name	Pediatric Surgery
Address	2-2 Yamadaoka, Suita
TEL	06-6879-3753
Email	okuyama@pedsurg.med.osaka-u.ac.jp

Public contact
Name of contact person	Takehisa Ueno
Organization	Osaka University Graduate School of Medicine
Division name	Pediatric Surgery
Address	2-2 Yamadaoka, Suita
TEL	06-6879-3753
Homepage URL
Email	ueno@pedsurg.med.osaka-u.ac.jp

Sponsor
Institute	AMED
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 11 Month 14 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 02 Month 01 Day
Anticipated trial start date	2013 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	Follow up 106 reported cases

Management information
Registered date	2016 Year 11 Month 08 Day
Last modified on	2016 Year 11 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028476