UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016197 |
|---|---|
| Receipt number | R000018701 |
| Scientific Title | Efficacy and safety of endoscopic submucosal dissection for colorectal lesions : multicenter prospective cohot study in Hiroshima area. |
| Date of disclosure of the study information | 2015/01/14 |
| Last modified on | 2015/01/13 11:34:43 |
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Basic information
Public title
Efficacy and safety of endoscopic submucosal dissection for colorectal lesions : multicenter prospective cohot study in Hiroshima area.
Acronym
Efficacy and safety of endoscopic submucosal dissection for colorectal lesions : multicenter prospective cohot study in Hiroshima area.
Scientific Title
Efficacy and safety of endoscopic submucosal dissection for colorectal lesions : multicenter prospective cohot study in Hiroshima area.
Scientific Title:Acronym
Efficacy and safety of endoscopic submucosal dissection for colorectal lesions : multicenter prospective cohot study in Hiroshima area.
Region
| Japan |
Condition
Condition
Colorectal adenoma or carcinoma resected by ESD
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of endoscopic submucosal dissection for colorectal adenoma or carcinoma in Hiroshima area
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of en bloc R0 resection and complications
Key secondary outcomes
Local reccurence rate after colorectal ESD
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
Consecutive patients who underwent colorectal ESD for colorectal adenoma or carcinoma
Key exclusion criteria
Less than 20 years old
Non-neoplastic colorectal lesions
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Tanaka |
Organization
Hiroshima University Hospital
Division name
Department of Endoscopy
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5538
colon@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Nagata |
Organization
Hiroshima City Asa Hospital
Division name
Department of Endoscopy
Zip code
Address
2-1-1 Kabeminami, Asakita-ku, Hiroshima, Japan
TEL
082-815-5211
Homepage URL
s-nagata@asa-hosp.city.hiroshima.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University 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
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 14 | 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
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | 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
Investigate the outcomes of ESD for colorectal adenoma or carcinoma and surveillance colonoscopy for 5 years.
Management information
Registered date
| 2015 | Year | 01 | Month | 13 | Day |
Last modified on
| 2015 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018701
