UMIN-CTR Clinical Trial

Basic information
Public title	Study of treatment for esophageal cancer
Acronym	Study of treatment for esophageal cancer
Scientific Title	Study of treatment for esophageal cancer
Scientific Title:Acronym	Study of treatment for esophageal cancer
Region	Japan

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

Objectives
Narrative objectives1	The aim of the present study was to assess the feasibility,complications,and morbidity of TPLE with MIE.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	postoperative complication and prognosis
Key secondary outcomes	none

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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	patients who underwent surgery for esophageal cancer from Jan 1997 to Dec 2018 received TPLE with gastric tube reconstruction via thoracoscopy.
Key exclusion criteria	thoracotomy, mediastinal endoscopy
Target sample size	26

Research contact person
Name of lead principal investigator	1st name Masaki Middle name Last name Mori
Organization	Graduate School of Medical Sciences,Kyushu University
Division name	Department of Surgery and Science
Zip code	812-8582
Address	3-1-1 Maidashi, Fukuoka
TEL	+81-92-642-5466
Email	m_mori@surg2.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Yasue Middle name Last name Kimura
Organization	Graduate School of Medical Sciences,Kyushu University
Division name	Department of Surgery and Science
Zip code	812-8582
Address	3-1-1 Maidashi, Fukuoka
TEL	+81-92-642-5466
Homepage URL
Email	yasuek@surg2.med.kyushu-u.ac.jp

Sponsor
Institute	Graduate School of Medical Sciences,Kyushu University
Institute
Department

Funding Source
Organization	Graduate School of Medical Sciences,Kyushu University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hospital ethical review committee
Address	3-1-1 Maidashi, Fukuoka
Tel	3-1-1 Maidashi, Fukuoka
Email	ijkseimei@jimu.kyushu-u.ac.jp

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	九州大学大学院消化器総合外科

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 26 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	26
Results
Results date posted	2020 Year 06 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 08 Month 31 Day
Date of IRB	2019 Year 08 Month 06 Day
Anticipated trial start date	2019 Year 08 Month 31 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	A retrospective study

Management information
Registered date	2020 Year 06 Month 26 Day
Last modified on	2020 Year 06 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046702