UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045465 |
|---|---|
| Receipt number | R000049578 |
| Scientific Title | Examination of local recurrence after endoscopic submucosal dissection for superficial colorectal tumors |
| Date of disclosure of the study information | 2021/09/13 |
| Last modified on | 2021/09/13 14:09:12 |
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Basic information
Public title
Examination of local recurrence after endoscopic submucosal dissection for superficial colorectal tumors
Acronym
Risk factors of local recurrence after ESD
Scientific Title
Examination of local recurrence after endoscopic submucosal dissection for superficial colorectal tumors
Scientific Title:Acronym
Risk factors of local recurrence after ESD
Region
| Japan |
Condition
Condition
More than 20mm superficial colorectal tumors which can be resected using endoscopy.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate risk factors after ESD for superficial colorectal tumors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
En-block R0 resection rate, curative resection rate, complication rate(perforation, postoperative bleeding)
Key secondary outcomes
tumor diameter, resected specimen diameter, macroscopic type, location, pathological characteristics, procedure time
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
20mm or more colorectal adenoma, intramucosal or slightly-invaded submucosal colorectal neoplasms were considered eligible.
Key exclusion criteria
1.Patients in disagreement with informed consent.
2.Patients unable to follow the course after colorectal ESD
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Taishi |
| Middle name | |
| Last name | Okumura |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
35-1, Chigasaki-chuo, Tsuduki,Yokohama, Kanagawa, Japan
TEL
045-949-7000
javier.thierry@gmail.com
Public contact
Name of contact person
| 1st name | Taishi |
| Middle name | |
| Last name | Okumura |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
35-1, Chigasaki-chuo, Tsuduki,Yokohama, Kanagawa, Japan
TEL
045-949-7000
Homepage URL
javier.thierry@gmail.com
Sponsor or person
Institute
Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Showa University Northern Yokohama 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
Showa University Northern Yokohama Hospital
Address
35-1, Chigasaki-chuo, Tsuduki,Yokohama, Kanagawa, Japan
Tel
045-949-7175
irb02syh@ofc.showa-u.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
| 2021 | Year | 09 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
1344
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
| 2003 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2003 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This retrospective study included 1344 patients, with a total of 1539 consecutive colorectal lesions, who underwent ESD from September 2003 to December 2019. The main outcome were incidence of local recurrence and its relationship with the clinicopathological factors in long term surveillance.
Management information
Registered date
| 2021 | Year | 09 | Month | 13 | Day |
Last modified on
| 2021 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049578
| 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 |
