UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044549 |
|---|---|
| Receipt number | R000050822 |
| Scientific Title | An open-label, single arm study assessing the usefulness of forward-viewing echoendoscope and difficulty factors for specimen collection in endoscopic ultrasound-guided fine-needle aspiration of gastric subepithelial lesions |
| Date of disclosure of the study information | 2021/06/16 |
| Last modified on | 2022/06/16 13:27:31 |
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Basic information
Public title
An open-label, single arm study assessing the usefulness of forward-viewing echoendoscope and difficulty factors for specimen collection in endoscopic ultrasound-guided fine-needle aspiration of gastric subepithelial lesions
Acronym
Flower study
Scientific Title
An open-label, single arm study assessing the usefulness of forward-viewing echoendoscope and difficulty factors for specimen collection in endoscopic ultrasound-guided fine-needle aspiration of gastric subepithelial lesions
Scientific Title:Acronym
Flower study
Region
| Japan |
Condition
Condition
gastric subepithelial lesion
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the usefulness of EUS-FNA for gastric subepithelial lesions using a forward-viewing echoendoscope and factors that make specimen collection difficult
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of specimens successfully collected with a forward-viewing echoendoscope
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Gastric SEL patients who are scheduled to undergo EUS-FNA and have a tumor diameter of 10 mm or more.
(2) 20 years old or older.
(3) The patient's free written consent to participate in this study has been obtained after sufficient explanation.
Key exclusion criteria
(1) Patients who are taking antithrombotic drugs and are unable to take a drug withdrawal or substitution in accordance with the "Guidelines for Gastrointestinal Endoscopy Care for Patients Taking Antithrombotic Drugs".
(2) Patients who are unable to give their consent for this study.
(3) Patients who are judged by the principal investigator to be unsuitable for this study.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Takuto |
| Middle name | |
| Last name | Hikichi |
Organization
Fukushima Medical University Hospital
Division name
Department of Endoscopy
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima, 960-1295, Japan
TEL
0245471583
takuto@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Minami |
| Middle name | |
| Last name | Hashimoto |
Organization
Fukushima Medeical University Hospital
Division name
Department of Endoscopy
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima, 960-1295, Japan
TEL
0245471583
Homepage URL
mi-hashi@fmu.ac.jp
Sponsor or person
Institute
Department of Endoscopy, Fukushima Medeical University Hospital
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
Fukushima Medeical University Hospital
Address
1 Hikarigaoka, Fukushima, 960-1295, Japan
Tel
0245471583
mi-hashi@fmu.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 | 06 | Month | 16 | 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
| 2020 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 06 | Month | 15 | Day |
Last modified on
| 2022 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050822
| 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 |
