UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of symptoms and quality of life after esophagectomy
Title of the study (Brief title)	Investigation of symptoms and quality of life after esophagectomy
Region	Japan

Condition
Condition	esophageal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We will correlate symptoms and QOL after esophagectomy with scores using our questionnaires.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	scoring of ES4/EGQ by questionnaires
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 patients who will undergo esophagectomy for esophageal cancer
Key exclusion criteria	The patient refuse to participate the study. The patient has relapse of the disease.
Target sample size	100

Research contact person
Name of lead principal investigator	Shinji Mine
Organization	Cancer Institute Hospital Ariake
Division name	Department of gastroenterological surgery
Address	3-8-31 Ariake Koto-ku Tokyo
TEL	03-3520-0111
Email	shinji.mine@jfcr.or.jp

Public contact
Name of contact person	Michitaka Honda
Organization	Cancer Institute Hospital Ariake
Division name	Department of gastroenterological surgery
Address	3-8-31 Ariake Koto-ku Tokyo
TEL	03-3520-0111
Homepage URL
Email	michitaka.honda@jfcr.or.jp

Sponsor
Institute	Cancer Institute Hospital Ariake
Institute
Department

Funding Source
Organization	Cancer Institute Hospital Ariake
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 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 04 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2017 Year 09 Month 30 Day
Date of closure to data entry	2017 Year 09 Month 30 Day
Date trial data considered complete	2017 Year 09 Month 30 Day
Date analysis concluded	2017 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	before study

Management information
Registered date	2015 Year 03 Month 30 Day
Last modified on	2017 Year 10 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019701