UMIN-CTR Clinical Trial

Basic information
Public title	Safety and efficacy of Video-Assisted Thoracoscopic Surgery for Esophageal cancer
Acronym	Safety and efficacy of Video-Assisted Thoracoscopic Surgery for Esophageal cancer
Scientific Title	Safety and efficacy of Video-Assisted Thoracoscopic Surgery for Esophageal cancer
Scientific Title:Acronym	Safety and efficacy of Video-Assisted Thoracoscopic Surgery for Esophageal cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of Video-Assisted Thoracoscopic operation for patients with esophageal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The harmful case that occurred within 30 days after the operation
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Video-Assisted Thoracoscopic operation
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	1. Histological diagnosis as the esophageal cancer 2. Esophageal lesion is in the thoracic esophagus (UICC-TNM 7th edition) 3. Single or multiple esophageal lesions 4. cT1-3, N0 (UICC 7th edition) 5. Aged over 20 years and under 80 years at the time of registration 6. Performance Status(ECOG):0 or 1 7. Previously not treated for esophageal cancer (Diagnosed as ycT1-3, N0 after the preoperative chemotherapy) 8. Previously not treated chemotherapy or radiotherapy for other cancers. 9. Previously not treated for the right side of body with the thoracotomy. (incl. thoracoscopic surgery) 10. Adequate organ function 11. Written IC
Key exclusion criteria	1. Tumor progress range: T4 (UICC 7th edition) 2. The central of lesion is at the esophago-gastric junction rather than the anal side. 3. Serious organ derangements 4. Serious active infections 5. Serious complications 6. Pregnant, lactating or women of child-bearing potential. 7. The patient is judged unsuitable for the subject of this study.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Makoto Sohda
Organization	Gunma University Hospital
Division name	Integrative Center of General Surgery
Zip code
Address	3-39-15 Showa-machi Maebashi Gunma 371-8511
TEL	027-220-8224
Email	msohda@gunma-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Makoto Sohda
Organization	Gunma University Hospital
Division name	Integrative Center of General Surgery
Zip code
Address	3-39-15 Showa-machi Maebashi Gunma 371-8511
TEL	027-220-8224
Homepage URL
Email	msohda@gunma-u.ac.jp

Sponsor
Institute	Gunma University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 07 Month 09 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
Results
Results date posted
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	2015 Year 05 Month 10 Day
Date of IRB	2015 Year 05 Month 14 Day
Anticipated trial start date	2015 Year 07 Month 09 Day
Last follow-up date	2020 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 07 Month 08 Day
Last modified on	2020 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020951