UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045574 |
|---|---|
| Receipt number | R000051920 |
| Scientific Title | Study of the usefulness of endoscopic resection for gastric submucosal tumors |
| Date of disclosure of the study information | 2021/09/30 |
| Last modified on | 2025/03/30 21:13:33 |
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Basic information
Public title
Study of the usefulness of endoscopic resection for gastric submucosal tumors
Acronym
Study of the usefulness of ER for gastric SMT
Scientific Title
Study of the usefulness of endoscopic resection for gastric submucosal tumors
Scientific Title:Acronym
Study of the usefulness of ER for gastric SMT
Region
| Japan |
Condition
Condition
Gastric submucosal tumor
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of endoscopic resection for gastric submucosal tumors
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endoscopic en bloc resection rate
Key secondary outcomes
Histological complete resection rate, endoscopic procedure complete resection rate, adverse event, procedure time.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Endoscopic resection
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients aged 20 years and over undergoing ESD for 11-30mm submucosal tumors (SMT) of the stomach
2) Not epithelial tumors
3) No ulcer
4) Intraluminal type
Key exclusion criteria
1) Patients with psychosis or psychiatric symptoms that would make participation in the study difficult.
2) Complications of poorly controlled heart failure
3) Respiratory disease requiring continuous oxygen administration.
4) Patients with end-stage renal disease.
5) Patients with uncompensated liver cirrhosis or liver failure
6) Patients with an apparent bleeding tendency
7) Patients on antithrombotic and anticoagulant medication who are unable to follow the standard recommendations for high-risk gastrointestinal endoscopy for bleeding in the Japanese Society of Gastrointestinal Endoscopy's "Guidelines for Gastrointestinal Endoscopy for Patients on Antithrombotic Drugs" and "Guidelines for Gastrointestinal Endoscopy for Patients on Antithrombotic Drugs--Addendum on Anticoagulants Including Direct (New) Oral Anticoagulants (DOAC) 2017".
8) Patients who are judged by the physician to be unsuitable for this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Kato |
Organization
Keio University, school of medicine
Division name
Gastroenterology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3437
motohikokato@keio.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Matsuura |
Organization
Keio University, school of medicine
Division name
Cancer center, division of research and development for minimal invasive treatment
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3437
Homepage URL
matsuura-no@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Keio University, school of medicine
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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 | 30 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 27 | Day |
Last modified on
| 2025 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051920
