UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032895 |
|---|---|
| Receipt number | R000037504 |
| Scientific Title | 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 | 2019/06/07 12:12:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Analysis of Clinicopathological Factors and Prognosis for Gastrointestinal Cancer Treated with Endoscopic Surgery (including Robotic Surgery)
Acronym
IUHW Endoscopic Surgery 2018
Scientific Title
Analysis of Clinicopathological Factors and Prognosis for Gastrointestinal Cancer Treated with Endoscopic Surgery (including Robotic Surgery)
Scientific Title:Acronym
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
| 1st name | Hironori |
| Middle name | |
| Last name | Ohdaira |
Organization
International University of Health and Welfare Hospital
Division name
Departments of Surgery
Zip code
3292763
Address
537-2 Iguchi, Nasushiobara, Tochigi 329-2763, Japan
TEL
0287-37-2221
ohdaira@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hironori |
| Middle name | |
| Last name | Ohdaira |
Organization
International University of Health and Welfare Hospital
Division name
Departments of Surgery
Zip code
329-2763
Address
537-2 Iguchi, Nasushiobara, Tochigi 329-2763, Japan
TEL
0287-37-2221
Homepage URL
ohdaira@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
International University of Health and Welfare Hospital
Address
537-2 Iguchi, Nasushiobara, Tochigi 329-2763, Japan
Tel
0287-37-2221
masa-takahashi@iuhw.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
| 2018 | Year | 06 | Month | 10 | 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
| 2018 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | 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 | 06 | Month | 06 | Day |
Last modified on
| 2019 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.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 |
