UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011045 |
|---|---|
| Receipt number | R000012928 |
| Scientific Title | Cytological findings of intraluminal lavage after colorectal endoscopic submucosal dissection |
| Date of disclosure of the study information | 2013/07/01 |
| Last modified on | 2015/06/27 09:52:24 |
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Basic information
Public title
Cytological findings of intraluminal lavage after colorectal endoscopic submucosal dissection
Acronym
Cytological findings of intraluminal lavage after colorectal endoscopic submucosal dissection
Scientific Title
Cytological findings of intraluminal lavage after colorectal endoscopic submucosal dissection
Scientific Title:Acronym
Cytological findings of intraluminal lavage after colorectal endoscopic submucosal dissection
Region
| Japan |
Condition
Condition
Colorectal tumor
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Examination of exfoliated tumor cells after colorectal endoscopic submucosal dissection end effectiveness of intraluminal lavage to remove exfoliated tumor cells
Basic objectives2
Others
Basic objectives -Others
exfoliated tumor cells of intraluminal lavage after colorectal endoscopic submucosal dissection
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
exfoliated tumor cells of intraluminal lavage before and after(beginning of lavage, after lavage of 500ml,1000ml,1500ml) colorectal endoscopic submucosal dissection
Key secondary outcomes
effectiveness of intraluminal lavage to remove exfoliated tumor cells after colorectal endoscopic submucosal dissection
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases of colorectal tumors resected en bloc by endoscopic submucosal dissection
Key exclusion criteria
Cases of incapacity decided by attending physicians
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Nakajima |
Organization
Nara Medical University
Division name
Departments of Surgery
Zip code
Address
840 Shijocho Kashihara,Nara,Japan
TEL
0744-22-3051
nakayosh@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadashi Nakagawa |
Organization
Nara Medical University
Division name
Departments of Surgery
Zip code
Address
840 Shijocho Kashihara, Nara
TEL
0744-22-3051
Homepage URL
nakatada@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
奈良県立医科大学付属病院(奈良県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | 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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational trial
Management information
Registered date
| 2013 | Year | 06 | Month | 26 | Day |
Last modified on
| 2015 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012928
| 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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