UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044313 |
|---|---|
| Receipt number | R000050406 |
| Scientific Title | The feasibility of endoscopic submucosal dissection for colorectal lesions larger than 10 cm; a retrospective multicenter study |
| Date of disclosure of the study information | 2021/05/25 |
| Last modified on | 2024/05/27 22:32:57 |
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Basic information
Public title
The feasibility of endoscopic submucosal dissection for colorectal lesions larger than 10 cm; a retrospective multicenter study
Acronym
ESD for huge colorectal lesions
Scientific Title
The feasibility of endoscopic submucosal dissection for colorectal lesions larger than 10 cm; a retrospective multicenter study
Scientific Title:Acronym
ESD for huge colorectal lesions
Region
| Japan |
Condition
Condition
Mucosal and submucosal colorectal neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate the feasibility and safety of ESD for huge colorectal lesions more than 10 cm
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
En bloc resection rate
Key secondary outcomes
curative resection rate, rate of adverse events, dissection speed, procedure time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
colorectal lesions more than 10 cm in diameter
Interventions/Control_2
colorectal lesions from 5cm to 10 cm in diameter
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
All cases that colorectal neoplasm is resected by endoscopic submucosal dissection
Key exclusion criteria
All the cases with endoscopic features suggesting obvious deep submucosal-invading cancer
Target sample size
320
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Chiba |
Organization
Omori Red Cross Hospital
Division name
Gastroenterology
Zip code
143-8527
Address
4-30-1, Chuo, Ota-Ku, Tokyo
TEL
0337753111
h.chiba04@gmail.com
Public contact
Name of contact person
| 1st name | Hideyuki |
| Middle name | |
| Last name | Chiba |
Organization
Omori Red Cross Hospital
Division name
Gastroenterology
Zip code
143-8527
Address
4-30-1, Chuo, Ota-Ku, Tokyo
TEL
0337753111
Homepage URL
h.chiba04@gmail.com
Sponsor or person
Institute
Omori Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
non
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
Omori Red Cross Hospital
Address
4-30-1, Chuo, Ota-Ku, Tokyo
Tel
0337753111
h.chiba04@gmail.com
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
NTT東日本関東病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 25 | Day |
Related information
URL releasing protocol
N/A doi: 10.1007/s00464-021-08916-x
Publication of results
Unpublished
Result
URL related to results and publications
N/A doi: 10.1007/s00464-021-08916-x
Number of participants that the trial has enrolled
320
Results
Main results and other details are provided in the paper.
Results date posted
| 2024 | Year | 05 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This retrospective study included 3591 consecutive colorectal lesions managed with ESD from June 2012 through December 2020. Clinicopathological characteristics and treatment outcomes were compared between lesions 10 cm wide and lesions 5-10 cm wide.
Participant flow
This retrospective study included 3591 consecutive colorectal lesions managed with ESD from June 2012 through December 2020.
Adverse events
Adverse events and other details were described in the article.
Outcome measures
Details of the evaluation parameters and other details were provided in the article.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospcective study
Management information
Registered date
| 2021 | Year | 05 | Month | 25 | Day |
Last modified on
| 2024 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050406
