UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051626 |
|---|---|
| Receipt number | R000058909 |
| Scientific Title | A prospective observational study of the effect of endoscopic ultrasound-guided fine needle aspiration/biopsy on treatment for gastrointestinal subepithelial lesions |
| Date of disclosure of the study information | 2023/07/18 |
| Last modified on | 2023/12/11 20:47:25 |
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Basic information
Public title
A prospective observational study of the effect of endoscopic ultrasound-guided fine needle aspiration/biopsy on treatment for gastrointestinal subepithelial lesions
Acronym
A prospective observational study of the effect of EUS-FNB on treatment for gastrointestinal subepithelial lesions
Scientific Title
A prospective observational study of the effect of endoscopic ultrasound-guided fine needle aspiration/biopsy on treatment for gastrointestinal subepithelial lesions
Scientific Title:Acronym
A prospective observational study of the effect of EUS-FNB on treatment for gastrointestinal subepithelial lesions
Region
| Japan |
Condition
Condition
subepithelial lesion of gastrointestinal tract
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the impact of pre-treatment endoscopic ultrasound-guided fine needle aspiration/biopsy (EUS-FNA/B) for gastrointestinal subepithelial lesions on various types of treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Outcome and safety of various treatment for gastrointestinal subepithelial lesions of which sample are obtained by EUS-FNA/B
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Suspected gastrointestinal subepithelial lesion by imaging diagnosis and judged to be an indication for EUS-FNA/B
2) At least 18 years of age at the time consent is obtained
3) Consent for participation in the study has been obtained from the patient
Key exclusion criteria
If the research physician determines that the candidate is inappropriate for this study
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Ishida |
Organization
Fukuoka University Faculty of Medicine
Division name
Division of Gastroenterology and Medicine
Zip code
814-0180
Address
7-45-1 Nanakuma, Johnan-ku, Fukuoka, Japan
TEL
092-801-1011
y.ishida.cb@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Ishida |
Organization
Fukuoka University Faculty of Medicine
Division name
Division of Gastroenterology and Medicine
Zip code
814-0180
Address
7-45-1 Nanakuma, Johnan-ku, Fukuoka, Japan
TEL
092-801-1011
Homepage URL
y.ishida.cb@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University - Medical Ethics Review Board
Address
7-45-1 Nanakuma, Johnan-ku, Fukuoka, Japan
Tel
092-801-1011
fumed-ethics@fukuoka-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
| 2023 | Year | 07 | Month | 18 | 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
| 2022 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 18 | 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
Patients with suspected subepithelial lesions of the gastrointestinal tract are enrolled, and EUS-FNA/B is performed as usual practice. Data will be collected on the status at the time of treatment (presence or absence of change of surgical technique, presence or absence of complications during treatment, in the case of surgery: intraoperative blood loss, operation time, in the case of endoscopic treatment: device, operation time, presence or absence of mucosal defect) and presence or absence of treatment-related complications, their detail and outcome.
Management information
Registered date
| 2023 | Year | 07 | Month | 16 | Day |
Last modified on
| 2023 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058909
| 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 |
