UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Attempt of quantitative evaluation of laryngeal movement before and after esophageal surgery
Title of the study (Brief title)	Attempt of quantitative evaluation of laryngeal movement before and after esophageal surgery
Region	Japan

Condition
Condition	esophageal cancer
Classification by specialty	Gastrointestinal surgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Before and after esophageal surgery, to quantitatively evaluate the laryngeal movement during swallowing.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	RSST(repetitive saliva swallowing test) MWST(modified water swallowing test) the elevation distance of the larynx during swallowing the elevation time of the larynx during swallowing
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	Not applicable
Gender	Male and Female
Key inclusion criteria	The diagnosis of esophageal cancer have been obtained by the histology. Surgical indications No severe complication Written informed concent A case of oral intake is allowed.
Key exclusion criteria	Esophagus bypass surgery There is a risk of aspiration.
Target sample size	20

Research contact person
Name of lead principal investigator	Junko Fujitani
Organization	National Center for Global Health and Medicine
Division name	Department of Rehabilitaion Medicine
Address	1-21-1 toyama shinzyuku-ku, Tokyo
TEL	03-3202-7181
Email	jufujita@hosp.ncgm.go.jp

Public contact
Name of contact person	Junko Fujitani
Organization	National Center for Global Health and Medicine
Division name	Department of Rehabilitaion Medicine
Address	1-21-1 toyama shinzyuku-ku, Tokyo
TEL	03-3202-7181
Homepage URL
Email	jufujita@hosp.ncgm.go.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	No
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	No

Other related organizations
Co-sponsor	No
Name of secondary funｄer(s)	No

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1	No
Study ID_2
Org. issuing International ID_2	No
IND to MHLW	なし

Institutions
Institutions	国立国際医療研究センター

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 21 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 12 Month 20 Day
Anticipated trial start date	2015 Year 12 Month 21 Day
Last follow-up date	2017 Year 02 Month 10 Day
Date of closure to data entry	2017 Year 02 Month 28 Day
Date trial data considered complete	2017 Year 02 Month 28 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	After esophageal cancer surgery, subjects needed to place jaws on the examination table of the equipment used in this study for measurement, but it was found that this movement was difficult and stopped. Although the research itself was discontinued, it is useful that after the operation of the esophageal cancer surgery, it was difficult for the subject to have a knowledge that even a slight movement of the jaw would be difficult, possibly causing aspiration.
Other related information	The design of this study is a cohort observational study.This study, before esophageal cancer surgery, is performed on patients there was a request preoperative rehabilitation, including the swallowing function support to the Department of Rehabilitation Medicine (However esophagus bypass surgery patients are excluded).This study is carried out for the cases allowed as study from the attending physician.Recruitment period is from January 2016 to June 2016.Up to six months is the observation period after surgery. Item to be measured is RSST(repetitive saliva swallowing test),MWST(modified water swallowing test),the elevation distance of the larynx during swallowing and the elevation time of the larynx during swallowing.

Management information
Registered date	2015 Year 12 Month 17 Day
Last modified on	2017 Year 07 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023373