UMIN-CTR Clinical Trial

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
Institute	Yuri kumiai general hospital
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044603