UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053280 |
|---|---|
| Receipt number | R000060806 |
| Scientific Title | Pancreatic cyst fluid analysis using endoscopic ultrasound-guided fine-needle aspiration specimens for diagnosis of pancreatic mucinous cystic neoplasms |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2024/05/11 21:36:48 |
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Basic information
Public title
Pancreatic cyst fluid analysis using endoscopic ultrasound-guided fine-needle aspiration specimens for diagnosis of pancreatic mucinous cystic neoplasms
Acronym
Pancreatic cyst fluid analysis using endoscopic ultrasound-guided fine-needle aspiration specimens for diagnosis of pancreatic mucinous cystic neoplasms
Scientific Title
Pancreatic cyst fluid analysis using endoscopic ultrasound-guided fine-needle aspiration specimens for diagnosis of pancreatic mucinous cystic neoplasms
Scientific Title:Acronym
Pancreatic cyst fluid analysis using endoscopic ultrasound-guided fine-needle aspiration specimens for diagnosis of pancreatic mucinous cystic neoplasms
Region
| Japan |
Condition
Condition
pancreatic cyst
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Mucinous cystic neoplasm (MCN) does not always present with typical clinical information or imaging findings, leading to occasional difficulties in differential diagnosis. In this study, cases were selected where clinical and imaging evidence suggested MCN, yet there were no indications of malignancy (tumor size . 4cm, intracystic nodules, elevated CA19-9). The aim was to perform cyst fluid analysis using EUS-FNA specimens for these cases, with the potential to contribute to treatment decision-making. The objective was to comprehensively diagnose MCN in these instances.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cyst fluid analysis sensitivity and specificity in MCN diagnosis determined by surgical specimens.
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
Pancreatic cystic lesion with a suspected mucinous cystic neoplasm (MCN), measuring 10mm or more and less than 40mm.
The cyst does not show intracystic nodules, and normal CA19-9 level.
Key exclusion criteria
(1)Cases where EUS-FNA is not feasible.
(2)Other cases deemed inappropriate by the principal investigator as study subjects.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Matsumoto |
Organization
Okayama University Hospital
Division name
Gastroenterology and Hepatology
Zip code
700-8558
Address
5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan
TEL
086-235-7219
pa793ygx@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Fujii |
Organization
Okayama University Hospital
Division name
Gastroenterology and Hepatology
Zip code
700-8558
Address
5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan
TEL
086-235-7219
Homepage URL
pmug1j9r@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Okayama University Hospital
Address
5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan
Tel
086-235-7219
pmug1j9r@s.okayama-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
| 2024 | Year | 06 | Month | 01 | 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 | 01 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Secondary Outcome:
Frequency and Severity of Complications of EUS-FNA for Cystic Lesions.
Management information
Registered date
| 2024 | Year | 01 | Month | 05 | Day |
Last modified on
| 2024 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060806
