UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049184 |
|---|---|
| Receipt number | R000056022 |
| Scientific Title | Changes in superior mesenteric artery and vein blood flow after esophagectomy |
| Date of disclosure of the study information | 2022/10/11 |
| Last modified on | 2022/10/11 15:42:48 |
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Basic information
Public title
Changes in superior mesenteric artery and vein blood flow after esophagectomy
Acronym
Changes in superior mesenteric artery and vein blood flow after esophagectomy
Scientific Title
Changes in superior mesenteric artery and vein blood flow after esophagectomy
Scientific Title:Acronym
Changes in superior mesenteric artery and vein blood flow after esophagectomy
Region
| Japan |
Condition
Condition
Esophageal cancer patients planned esophagectomy
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal influence of invasion from esophagectomy to superior mesenteric artery and vein blood flow
Basic objectives2
Others
Basic objectives -Others
To reveal the relationship of superior mesenteric artery and vein blood flow and intestinal function
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in superior mesenteric artery and vein blood flow after esophagectomy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Esophageal cancer patients planned esophagectomy at University of Tokyo Hospital and agreed to participate in this study in documents
Key exclusion criteria
Patients under 20 years old or who are inappropriate for this study judged by doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Fukatsu |
Organization
University of Tokyo Hospital
Division name
Surgical Center
Zip code
113-8655
Address
7-3-1, Bunkyo-ku Hongou, Tokyo
TEL
03-3815-5411
fukatsu-1su@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Narita |
Organization
University of Tokyo Hospital
Division name
Gastrointestinal Surgery
Zip code
113-8655
Address
7-3-1, Bunkyo-ku Hongou, Tokyo
TEL
03-3815-5411
Homepage URL
tomnrt@outlook.jp
Sponsor or person
Institute
The University of Tokyo, Clinical Research Review Board
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo 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
The University of Tokyo, Clinical Research Review Board
Address
7-3-1, Bunkyo-ku Hongou, Tokyo
Tel
03-5841-3557
ethics@m.u-tokyo.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
| 2022 | Year | 10 | 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
| 2022 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Changes in superior mesenteric artery and vein blood flow after esophagectomy
Management information
Registered date
| 2022 | Year | 10 | Month | 11 | Day |
Last modified on
| 2022 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056022
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
