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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032895
Receipt No. R000037504
Official scientific title of the study Analysis of Clinicopathological Factors and Prognosis for Gastrointestinal Cancer Treated with Endoscopic Surgery (including Robotic Surgery)
Date of disclosure of the study information 2018/06/10
Last modified on 2018/06/06

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Basic information
Official scientific title of the study Analysis of Clinicopathological Factors and Prognosis for Gastrointestinal Cancer Treated with Endoscopic Surgery (including Robotic Surgery)
Title of the study (Brief title) IUHW Endoscopic Surgery 2018
Region
Japan

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

Objectives
Narrative objectives1 These days, the number of endoscopjc suregry for gastrointestinal cancer has been increasing.
There are some problems, however, complicaitons and early reccurence after endoscopjc suregry has been reported. Indications of endoscopjc suregry are differnt in each institution, association and guidelie.
The purpose of this study is to analyze clinicopathological factors and prognosis for gastrointestinal cancer treated with endoscopic surgery (including robotic surgery) prospectively.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes overall survival
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 endoscopic surgery (including robot 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria gastrointestinal cancer patients who agreed to endoscopic surgery (including robot surgery) (gasric cancer, esophageal cancer, colorectal cancer)
Key exclusion criteria patients who didn't hope endoscopic surgery
Target sample size 450

Research contact person
Name of lead principal investigator Hironori Ohdaira
Organization International University of Health and Welfare Hospital
Division name Departments of Surgery
Address 537-2 Iguchi, Nasushiobara, Tochigi 329-2763, Japan
TEL 0287-37-2221
Email ohdaira@iuhw.ac.jp

Public contact
Name of contact person Hironori Ohdaira
Organization International University of Health and Welfare Hospital
Division name Departments of Surgery
Address 537-2 Iguchi, Nasushiobara, Tochigi 329-2763, Japan
TEL 0287-37-2221
Homepage URL
Email ohdaira@iuhw.ac.jp

Sponsor
Institute International University of Health and Welfare Hospital
Institute
Department

Funding Source
Organization International University of Health and Welfare Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

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 06 Month 10 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 05 Month 24 Day
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 06 Day
Last modified on
2018 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037504

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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