UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050464 |
|---|---|
| Receipt number | R000057467 |
| Scientific Title | Endoscopic resection for gastric submucosal tumors: Japanese multicenter retrospective study |
| Date of disclosure of the study information | 2023/03/01 |
| Last modified on | 2023/03/01 19:46:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Endoscopic resection for gastric submucosal tumors
Acronym
Endoscopic resection for gastric SMT
Scientific Title
Endoscopic resection for gastric submucosal tumors: Japanese multicenter retrospective study
Scientific Title:Acronym
Endoscopic resection for gastric SMT
Region
| Japan |
Condition
Condition
gastric submucosal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy and safety of endoscopic resection for gastric submucosal tumor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the rate of complete endoscopic resection
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with gastric SMT for whom ER was performed were consecutively enrolled from the first case until August 2020.
Key exclusion criteria
Patients for whom a laparoscopic or port-assisted procedure was initially planned were excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Uedo |
| Middle name | |
| Last name | Noriya |
Organization
Osaka International Cancer Institute
Division name
Department of Gastrointestinal Oncology
Zip code
5418567
Address
3-1-69, Otemae, Chuo-ku, Osaka
TEL
06-6945-1181
noriya.uedo@oici.jp
Public contact
Name of contact person
| 1st name | Shichijo |
| Middle name | |
| Last name | Satoki |
Organization
Osaka International Cancer Institute
Division name
Department of Gastrointestinal Oncology
Zip code
5418567
Address
3-1-69, Otemae, Chuo-ku, Osaka
TEL
06-6945-1181
Homepage URL
7satoki@oici.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
None
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
Institutional Review Board of the Osaka International Cancer Institute
Address
3-1-69, Otemae, Chuo-ku, Osaka
Tel
06-6945-1181
rinri01@opho.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
| 2023 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/den.14446
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/den.14446
Number of participants that the trial has enrolled
117
Results
Endoscopic complete resection was achieved in 117 (99%) lesions.
Results date posted
| 2023 | Year | 03 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Till August 2020, 117 patients with 118 lesions had undergone ER for gastric SMT in the 12 facilities.
Participant flow
Till August 2020, 117 patients with 118 lesions had undergone ER for gastric SMT in the 12 facilities.
Adverse events
Two cases of delayed bleeding required endoscopic hemostasis, one of which required blood transfusion.
Outcome measures
Endoscopic complete resection was achieved in 117 (99%) lesions.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We conduct this study to elucidate the current scenario of endoscopic resection for gastric submucosal tumors in Japanese endoscopic practice. Patients (from 12 institutions) with gastric submucosal tumors who underwent endoscopic resection were enrolled from the first case until August 2020.
Management information
Registered date
| 2023 | Year | 03 | Month | 01 | Day |
Last modified on
| 2023 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057467
