UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039109
Receipt number R000044603
Scientific Title Usefulness of cricoid pressure for patients with poor observation due to poor gastric wall extension in upper gastrointestinal endoscopy
Date of disclosure of the study information 2020/01/10
Last modified on 2021/05/31 09:55:12

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Basic information

Public title

Usefulness of cricoid pressure for patients with poor observation due to poor gastric wall extension in upper gastrointestinal endoscopy

Acronym

Usefulness of cricoid pressure for patients with poor observation due to poor gastric wall extension in upper gastrointestinal endoscopy

Scientific Title

Usefulness of cricoid pressure for patients with poor observation due to poor gastric wall extension in upper gastrointestinal endoscopy

Scientific Title:Acronym

Usefulness of cricoid pressure for patients with poor observation due to poor gastric wall extension in upper gastrointestinal endoscopy

Region

Japan


Condition

Condition

upper gastrointestinal endoscopy

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to evaluate whether cricoid pressure is useful for patients with upper gastrointestinal endoscopy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Observation success rate of the greater curvature of the upper body by using cricoid presssure

Key secondary outcomes

Time to successful cricoid pressure
SpO2 changes during the cricoid pressure
Complications associated with the procedure


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

cricoid pressure

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

85 years-old >

Gender

Male and Female

Key inclusion criteria

PS (ECOG) is 0.1.2.
Consent has been obtained from the patient.

Key exclusion criteria

Patient after gastrectomy.
Patients with poor gastric wall extension associated with disease.
Anatomically unfavorable cricoid pressure.
Pregnant
Lactating

Target sample size

2000


Research contact person

Name of lead principal investigator

1st name Toshiki
Middle name
Last name horii

Organization

Yuri kumiai general hospital

Division name

Division of gastroenterology

Zip code

015-8511

Address

38 kawaguchi-yago, yurihonjo-shi, Akita

TEL

0184-27-1200

Email

soumukanri@yuri-hospital.honjo.akita.jp


Public contact

Name of contact person

1st name Toshiki
Middle name
Last name Horii

Organization

Yuri kumiai general hospital

Division name

Division of gastroenterology

Zip code

015-8511

Address

38 kawaguchi-yago, yurihonjo-shi, Akita

TEL

0184-27-1200

Homepage URL


Email

horiitoshiki@gmail.com


Sponsor or person

Institute

Yuri kumiai general hospital

Institute

Department

Personal name



Funding Source

Organization

non

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

Yuri kumiai general hospital

Address

38 kawaguchi-yago, yurihonjo-shi, Akita

Tel

0184-27-1200

Email

soumukanri@yuri-hospital.honjo.akita.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

2020 Year 01 Month 10 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


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 09 Month 16 Day

Date of IRB

2019 Year 09 Month 17 Day

Anticipated trial start date

2019 Year 10 Month 01 Day

Last follow-up date

2020 Year 09 Month 30 Day

Date of closure to data entry

2021 Year 01 Month 11 Day

Date trial data considered complete

2021 Year 01 Month 11 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 01 Month 09 Day

Last modified on

2021 Year 05 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044603


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name