UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048864 |
|---|---|
| Receipt number | R000055097 |
| Scientific Title | Appropriate Conditions of Gastric Endoscopic Submucosal Dissection for Beginners: a retrospective study |
| Date of disclosure of the study information | 2022/09/06 |
| Last modified on | 2022/09/06 18:08:59 |
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Basic information
Public title
Appropriate Conditions of Gastric Endoscopic Submucosal Dissection for Beginners: a retrospective study
Acronym
Appropriate Conditions of Gastric Endoscopic Submucosal Dissection for Beginners: a retrospective study
Scientific Title
Appropriate Conditions of Gastric Endoscopic Submucosal Dissection for Beginners: a retrospective study
Scientific Title:Acronym
Appropriate Conditions of Gastric Endoscopic Submucosal Dissection for Beginners: a retrospective study
Region
| Japan |
Condition
Condition
early gastric neoplasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
we conducted a retrospective study with the aim of verifying the predictors for gastric ESD that can be safely performed even with beginner.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the predictors of lesions that meet all the conditions that ESD can be performed by a beginner, with a procedure time of 60 minutes or less, complete pathological resection, and no severe complications, and self-completed.
Key secondary outcomes
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
Early gastric cancer and gastric adenoma who underwent endoscopic submucosal dissection at Showa University Hospital from January 2015 to December 2021
Key exclusion criteria
Lesions whose histopathological diagnosis was other than gastric cancer or gastric adenoma
Target sample size
466
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Katagiri |
Organization
Showa university hospital
Division name
Division of Gastroenterology, Department of Medicine
Zip code
1428666
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
03-3784-8535
katsushi@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Ataushi |
| Middle name | |
| Last name | Katagiri |
Organization
Showa university hospital
Division name
Division of Gastroenterology, Department of Medicine
Zip code
1428666
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
0337848535
Homepage URL
katsushi@med.showa-u.ac.jp
Sponsor or person
Institute
Showa university
Institute
Department
Personal name
Funding Source
Organization
Showa university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Tokyo
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Showa University Review Board
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan
Tel
03-3784-8129
m-rinri@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
| 2022 | Year | 09 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 09 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The lesions were divided into two groups according to ESD experience of operator as follows; the ESD beginner (EB) group (ESD experience < 50) and the ESD non-beginner (ENB) group (ESD experience > 50). Relationships between difficult ESD (having at least one of the following items; procedure time > 60 min, incomplete resection, change of operator, occurrence of severe complication) and clinicopathological findings of the lesion were analyzed.
Management information
Registered date
| 2022 | Year | 09 | Month | 06 | Day |
Last modified on
| 2022 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055097
| 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 |
