UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024772
Receipt number R000028476
Scientific Title Study for prognosis factors of intestinal failure
Date of disclosure of the study information 2016/11/14
Last modified on 2016/11/08 22:57:02

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Basic information

Public title

Study for prognosis factors of intestinal failure

Acronym

Study for intestinal failure

Scientific Title

Study for prognosis factors of intestinal failure

Scientific Title:Acronym

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

1st name
Middle name
Last name Hiroomi Okuyama

Organization

Osaka University Graduate School of Medicine

Division name

Pediatric Surgery

Zip code


Address

2-2 Yamadaoka, Suita

TEL

06-6879-3753

Email

okuyama@pedsurg.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takehisa Ueno

Organization

Osaka University Graduate School of Medicine

Division name

Pediatric Surgery

Zip code


Address

2-2 Yamadaoka, Suita

TEL

06-6879-3753

Homepage URL


Email

ueno@pedsurg.med.osaka-u.ac.jp


Sponsor or person

Institute

AMED

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Partially published


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

No longer recruiting

Date of protocol fixation

2013 Year 02 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028476


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name