UMIN-CTR Clinical Trial

Basic information
Public title	Clinical evaluation of the safety of robotic esophagectomy using da Vinci surgical system (DVSS) for resectable esophageal cancer
Acronym	Robotic esophagectomy for esophageal cancer
Scientific Title	Clinical evaluation of the safety of robotic esophagectomy using da Vinci surgical system (DVSS) for resectable esophageal cancer
Scientific Title:Acronym	Robotic esophagectomy 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 clarify safety of robotic esophagectomy using DVSS for esophageal cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Postoperative complications greater than Grade III according to Clavien-Dindo classification during 30 days after surgery
Key secondary outcomes	Postoperative complications greater than Grade II according to Clavien-Dindo classification during 30 days after surgery Completion rate of robot assised surgery The incidence of Intraoperative adverse effects Surgery-related mortality

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
Interventions/Control_1	Robotic surgery
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Histologically diagnosed primary esophageal squamous cell carcinoma or adenocarcinoma 2) cStage I, II or III disease curably treated with radical esophagectomy 3) Not indicated for endoscopic resection 4) Informed consent is obtained
Key exclusion criteria	1) Patients with psychiatric or mental disorders 2) Preoperative therapy excluding non-curative endoscopic resection and standarad neoadjuvant chemotherapy for cStageII/III disease 3) Possibly pregnant, or breast feeding woman 4) Paticents with acute myocardial infaction in 6 months or with unstable ungina
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Hiroya Middle name Last name Takeuchi
Organization	Hamamatsu University School of Medicine
Division name	Department of Surgery
Zip code	431-3192
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, JAPAN
TEL	053-435-2279
Email	takeuchi@hama-med.ac.jp

Public contact
1st name of contact person	1st name Yoshihiro Middle name Last name Hiramatsu
Organization	Hamamatsu University School of Medicine
Division name	Department of Surgery
Zip code	431-3192
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, JAPAN
TEL	053-435-2279
Homepage URL
Email	hiramatu@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Hamamatsu University 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)

IRB Contact (For public release)
Organization	Ethics Committee of Hamamatsu University School of Medicine (EC HUSM)
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, JAPAN
Tel	053-435-2680
Email	rinri@hama-med.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	2017 Year 10 Month 01 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	Open public recruiting
Date of protocol fixation	2017 Year 09 Month 08 Day
Date of IRB	2017 Year 10 Month 12 Day
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date	2022 Year 12 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	2017 Year 09 Month 08 Day
Last modified on	2019 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032850