UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047725 |
|---|---|
| Receipt number | R000053492 |
| Scientific Title | The feasibility of endoscopic submucosal dissection for gastric lesions larger than 5 cm; a retrospective multicenter study |
| Date of disclosure of the study information | 2022/05/12 |
| Last modified on | 2022/05/11 19:25:09 |
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Basic information
Public title
The feasibility of endoscopic submucosal dissection for gastric lesions larger than 5 cm; a retrospective multicenter study
Acronym
The feasibility of ESD for gastric lesions larger than 5 cm
Scientific Title
The feasibility of endoscopic submucosal dissection for gastric lesions larger than 5 cm; a retrospective multicenter study
Scientific Title:Acronym
The feasibility of ESD for gastric lesions larger than 5 cm
Region
| Japan |
Condition
Condition
Mucosal and submucosalgastric 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 large gastric lesions more than 5 cm
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
En bloc resection rate
Key secondary outcomes
curative resection rate, submucosal fibrosis during ESD, procedure time rate of adverse events
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
gastric lesions more than 5 cm in diameter
Interventions/Control_2
gastric lesions less than 5 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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All cases that gastric 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
2000
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 12 | 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
3474
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
| 2022 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 11 | Day |
Last modified on
| 2022 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053492
