UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	To assess the safety and establish the risk model of thoracoscopic esophagectomy in our country
Title of the study (Brief title)	To assess the safety and establish the risk model of thoracoscopic esophagectomy in our country
Region	Japan

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

Objectives
Narrative objectives1	To assess the safety and establish the risk model of thoracoscopic esophagectomy in our country
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	postoperative morbidity rate mortality rate within 30 days inhospital mortality rate
Key secondary outcomes

Base
Study type

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	video-assisted thoracoscopic esophagectomy and lymph node dissection
Interventions/Control_2	transthoracic esophagectomy and lymph node dissection
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	Patients undergoing esophagectomy and enrolled to NCD datebase in 2011 and 2012.
Key exclusion criteria	Patients whose doctor judged to be ineligible for this study.
Target sample size	3500

Research contact person
Name of lead principal investigator	Yuko Kitagawa
Organization	Keio University School of Medicine
Division name	Department of Surgery
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	03-3353-6440
Email	kitagawa@a3.keio.jp

Public contact
Name of contact person	Hiroya Takeuchi
Organization	Keio University School of Medicine
Division name	Department of Surgery
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	03-3353-6440
Homepage URL
Email	htakeuchi@a6.keio.jp

Sponsor
Institute	The Japan Esophageal Society
Institute
Department

Funding Source
Organization	The Japan Esophageal Society
Organization
Division
Category of Funding Organization	Other
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 01 Month 31 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 04 Month 26 Day
Anticipated trial start date	2015 Year 01 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 01 Month 31 Day
Last modified on	2018 Year 08 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019052