UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038776
Receipt number R000044206
Scientific Title Study on risk factors of perioperative bleeding of percutaneous endoscopic gastrostomy
Date of disclosure of the study information 2019/12/03
Last modified on 2019/12/03 18:40:26

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Basic information

Public title

Study on risk factors of perioperative bleeding of percutaneous endoscopic gastrostomy

Acronym

Perioperative bleedng of PEG

Scientific Title

Study on risk factors of perioperative bleeding of percutaneous endoscopic gastrostomy

Scientific Title:Acronym

Perioperative bleedng of PEG

Region

Japan


Condition

Condition

Oral intake impossible

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To reveal the risk factors of perioperable bleeding of percutaneous endoscopic gastrostomy

Basic objectives2

Others

Basic objectives -Others

risk facter

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison of background factors between patients with and without treatment-related bleeding

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

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients undergone percutaneous endoscopic gastrectomy

Key exclusion criteria

none

Target sample size

62


Research contact person

Name of lead principal investigator

1st name Toshihisa
Middle name
Last name Takeuchi

Organization

Osaka medical college hospital

Division name

Gastrointestinal endoscopy center

Zip code

569-8686

Address

2-7, Daigaku-machi, Takatsuki

TEL

072-683-1221

Email

in2097@osaka-med.ac.jp


Public contact

Name of contact person

1st name Kazuhiro
Middle name
Last name Ota

Organization

Osaka medical college

Division name

Second department of internal medicine

Zip code

569-8686

Address

2-7, Daigaku-machi, Takatsuki

TEL

072-683-1221

Homepage URL


Email

clash_kaz@yathoo.co.jp


Sponsor or person

Institute

Osaka medical college

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethic review committee at osaka medical college

Address

2-7, Daigaku-machi, Takatsuki

Tel

072-683-1221

Email

omc_rinsyou@osaka-med.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



Other administrative information

Date of disclosure of the study information

2019 Year 12 Month 03 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

62

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

Completed

Date of protocol fixation

2019 Year 11 Month 05 Day

Date of IRB

2019 Year 12 Month 03 Day

Anticipated trial start date

2019 Year 12 Month 03 Day

Last follow-up date

2019 Year 12 Month 03 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Retrospective study


Management information

Registered date

2019 Year 12 Month 03 Day

Last modified on

2019 Year 12 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044206


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name