UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective randomized controlled study about the effectiveness of the continuous insufflation method for the observation of cervical esophagus.
Title of the study (Brief title)	Continuous insufflation method study
Region	Japan

Condition
Condition	none
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of the continuous insufflation method for the observation of cervical esophagus.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Observation rate of palisade vessels in cervical esophagus (Continuous insufflation group vs control group)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	Continuous insufflation during the observation of cervical esophagus
Interventions/Control_2	Conventional observation
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients who undergo esophagogastroduodenoscopy
Key exclusion criteria	1.The patients who rejected informed consent 2.The patients who have a history of therapy for cervical esophagus cancer. 3.The patients who have stenosis of cervical esophagus 4.The patients who can not hold their breath
Target sample size	200

Research contact person
Name of lead principal investigator	Takaaki Kishino
Organization	Nara City Hospital
Division name	Gastroenterology
Address	1-50-1 Higashikideracho, Nara, Nara, Japan.
TEL	0742-24-1251
Email	kishinotakaaki@hotmail.co.jp

Public contact
Name of contact person	Takaaki Kishino
Organization	Nara City Hospital
Division name	Gastroenterology
Address	1-50-1 Higashikideracho, Nara, Nara, Japan.
TEL	0742-24-1251
Homepage URL
Email	kishinotakaaki@hotmail.co.jp

Sponsor
Institute	nara city hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
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	2015 Year 12 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 14 Day
Anticipated trial start date	2015 Year 12 Month 21 Day
Last follow-up date	2016 Year 05 Month 31 Day
Date of closure to data entry	2016 Year 05 Month 31 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Observation rate of palisade vessels in cervical esophagus Continuous insufflation group 67% Control group 22% risk ratio 3.05(2.1-4.5)
Other related information

Management information
Registered date	2015 Year 12 Month 15 Day
Last modified on	2017 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023328