UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Long-term quality-of-life evaluation in patients after Esophagectomy by EORTC QLQ-OES and C-30
Title of the study (Brief title)	The QOL evaluation in patients after esophagectomy
Region	Japan

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

Objectives
Narrative objectives1	To estimate the quality-of-life in patients after Esophagectomy by EORTC QLQ-OES and C-30
Basic objectives2	Others
Basic objectives -Others	To clarify the effect of surgical approach, reconstruction route, and other clinico-pathological factors on QOL.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	aw scores of each QOL questionnaire (EORTC QLQ-OES and C-30)and VAS
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)patients underwent subtotal esophagectomy for esophageal cancer 2) Provided written informed consent
Key exclusion criteria	1) Considered inadequate for inclusion in this trial by the physician 2) Patients without consent for enrollment
Target sample size	200

Research contact person
Name of lead principal investigator	Masahiko Koike
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery (Surgery II)
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL	052-744-2250
Email	dockoike@med.nagoya-u.ac.jp

Public contact
Name of contact person	Yukiko Niwa
Organization	Nagoya University Hospital
Division name	Quality and Patient Safety
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL	052-744-2250
Homepage URL
Email	yukiko-niwa@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine
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	2016 Year 02 Month 19 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 02 Month 11 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 09 Month 30 Day
Date trial data considered complete	2022 Year 12 Month 31 Day
Date analysis concluded	2023 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Prospective single-institutional study, In patients fulfilling the criteria, QOL survey will carry out using EORTC-QLQ-C30/OES18. Survey is scheduled as follows; EORTC-QLQ-C30/OES18: preoperatively, on discharge, on postoperative 6,12,24-month.

Management information
Registered date	2016 Year 02 Month 12 Day
Last modified on	2018 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023931