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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034098
Receipt No. R000038864
Scientific Title A phase II study of robot assisted esophagectomy with nodal dissection for esophageal cancer
Date of disclosure of the study information 2018/09/11
Last modified on 2019/03/14

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Basic information
Public title A phase II study of robot assisted esophagectomy with nodal dissection for esophageal cancer
Acronym A phase II study of robot assisted esophagectomy
Scientific Title A phase II study of robot assisted esophagectomy with nodal dissection for esophageal cancer
Scientific Title:Acronym A phase II study of robot assisted esophagectomy
Region
Japan

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

Objectives
Narrative objectives1 To determine the efficacy and safety of robotic assisted esophagectomy for esophageal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Post operative recurrent laryngeal nerve paralysis and pneumonia
Key secondary outcomes Overall survival
Recurrence free survival
Completion rate of the robotic assisted surgery
Other postoperative complications

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 Introduce a robotic assisted esophagectomy for resectable thoracic esophageal cancer patients.
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 resectable thoracic esophageal cancer
Key exclusion criteria 1) Having other active cancers
2) Possibly pregnant, or breast feeding woman
3) with psychiatric disorder
4) Receiving steroids
5) With Acute myocardial infaction in 6 months or with unstable ungina
6) With uncontrolled hypertention
7) With uncontrolled diabetes mellitus
8) With pulmonary disease and require continuous oxygen therapy
Target sample size 26

Research contact person
Name of lead principal investigator
1st name Shinsuke
Middle name
Last name Sato
Organization Shizuoka General Hospital
Division name Department of Gastroenterological Surgery
Zip code 420-8527
Address 4-27-1 Kitaanndo, Aoi-ku, Shizuoka
TEL 0542476111
Email shinsukesato@gmail.com

Public contact
Name of contact person
1st name Shinsuke
Middle name
Last name Sato
Organization Shizuoka General Hospital
Division name Department of Gastroenterological Surgery
Zip code 420-8527
Address 4-27-1 Kitaanndo, Aoi-ku, Shizuoka
TEL 054-247-6111
Homepage URL
Email shinsukesato@gmail.com

Sponsor
Institute Shizuoka General Hospital
Institute
Department

Funding Source
Organization Shizuoka General Hospital
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 Shizuoka General Hospital
Address 4-27-1 Kitaando, Aoiku, Shizuoka
Tel 0542476111
Email chiken-sougou@shizuoka-pho.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
2018 Year 09 Month 11 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 Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 12 Day
Date of IRB
2018 Year 06 Month 12 Day
Anticipated trial start date
2018 Year 09 Month 11 Day
Last follow-up date
2028 Year 09 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 11 Day
Last modified on
2019 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038864

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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