UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053924 |
|---|---|
| Receipt number | R000061193 |
| Scientific Title | Safety and utility of Endoscopic Ultrasound-guided Fine Needle Aspiration |
| Date of disclosure of the study information | 2024/03/21 |
| Last modified on | 2024/03/21 10:41:30 |
* 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
Safety and utility of Endoscopic Ultrasound-guided Fine Needle Aspiration
Acronym
Observational study of EUS-FNA
Scientific Title
Safety and utility of Endoscopic Ultrasound-guided Fine Needle Aspiration
Scientific Title:Acronym
Observational study of EUS-FNA
Region
| Japan |
Condition
Condition
Patients who underwent EUS-FNA or interventional EUS
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To elucidate the utility and safety of Endoscopic Ultrasound-Guided Fine Needle Aspiration (EUS-FNA) and related procedures by examining clinical information about EUS-FNA cases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic ability
Key secondary outcomes
1. Specimen acquisition rate
2. Others
a. Patient background (age, gender, medical history, presence of antithrombotic drug use, other medication history, lifestyle, current medical conditions, etc.)
b. Imaging diagnosis (pre-EUS-FNA diagnosis, imaging findings from CT, MRI, US, EUS, endoscopy, etc.)
c. Examination results (number of punctures, puncture routes, specimen acquisition rate, diagnostic accuracy, etc.)
d. Submucosal tumors of the gastrointestinal tract: For GIST and neuroendocrine tumors (NET/NEC), the concordance rate of the MIB-1 index between FNA specimens and surgical specimens is
also evaluated.
e. Pancreatic tumors: Particularly, the diagnostic capability for typical pancreatic cancer, neuroendocrine tumors (NET/NEC), and autoimmune pancreatitis (AIP) is assessed. Additionally,
for NET/NEC, the concordance rate of the MIB-1 index between FNA specimens and surgical specimens is also evaluated.
f. Therapeutic outcomes related to EUS-guided biliary drainage or EUS-guided pancreatic cyst drainage, etc., associated with EUS-FNA.
g. Incidental events (frequency of bleeding, perforation, infection, peritoneal seeding, etc., and their management)
h. Clinical course after examination (surgery, chemotherapy, observation, etc.)
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
All patients who underwent EUS-FNA or related procedures for definitive diagnosis at Fukushima Medical University Hospital and collaborating research institutions from January 2001 to December 2033.
Key exclusion criteria
All patients who decline to participate in the study.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Rei |
| Middle name | |
| Last name | Suzuki |
Organization
Fukushima Medical University
Division name
Department of Gastroenterology
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima, Japan
TEL
024-547-1202
subaru@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Rei |
| Middle name | |
| Last name | Suzuki |
Organization
Fukushima Medical University
Division name
Department of Gastroenterology
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima, Japan
TEL
024-547-1202
Homepage URL
subaru@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fukushima Rosai Hospital, Fukushima Red Cross Hospital, Soma General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
1 Hikarigaoka, Fukushima, Japan
Tel
0245471202
rs@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
| 2024 | Year | 03 | Month | 21 | 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
| 2024 | Year | 03 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 21 | Day |
Last follow-up date
| 2033 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort study
Management information
Registered date
| 2024 | Year | 03 | Month | 21 | Day |
Last modified on
| 2024 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061193
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
