UMIN-CTR Clinical Trial

Basic information
Public title	Robotic assisted thoracoscopic subtotal esophagectomy with reconstruction for esophageal cancer
Acronym	Robotic assisted esophagectomy
Scientific Title	Robotic assisted thoracoscopic subtotal esophagectomy with reconstruction for esophageal cancer
Scientific Title:Acronym	Robotic assisted esophagectomy
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 determine the efficacy and safety of robotic assisted thoracoscopic esophagectomy with reconstruction for esophageal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intraoperative blood loss Duration of operation Number of harvested lymph node
Key secondary outcomes	Length of postoperative hospital stay Postoperative course Postoperative complication Disease free survival

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	Device,equipment Maneuver
Interventions/Control_1	Robotic assisted thoracoscopic subtotal esophagectomy with reconstruction for esophageal cancer was performed from approval to 31st, Dec/2019.
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	Esophageal cancer indicated for thoracoscopic esophagectomy
Key exclusion criteria	T4 tumors (Tumors invades adjacent structures)
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Satoru Middle name Last name Motoyama
Organization	Akita University Hospital
Division name	Esophageal Surgery
Zip code	0108543
Address	1-1-1 Hondo, Akita
TEL	0188846132
Email	motoyama@doc.med.akita-u.ac.jp

Public contact
Name of contact person	1st name Satoru Middle name Last name Motoyama
Organization	Akita University Hospital
Division name	Esophageal Surgery
Zip code	0108543
Address	1-1-1 Hondo, Akita
TEL	0188846132
Homepage URL
Email	motoyama@doc.med.akita-u.ac.jp

Sponsor
Institute	Akita University Hospital
Institute
Department

Funding Source
Organization	Akita University Hospital
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	Akita University Hospital
Address	1-1-1 Hondo, Akita
Tel	0188341111
Email	soken@hos.akita-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

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 02 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	13
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	2014 Year 12 Month 02 Day
Date of IRB	2014 Year 10 Month 14 Day
Anticipated trial start date	2014 Year 12 Month 02 Day
Last follow-up date	2023 Year 03 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	2014 Year 12 Month 02 Day
Last modified on	2019 Year 09 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018409