UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049965 |
|---|---|
| Receipt number | R000056908 |
| Scientific Title | Real diagnostic ability of endoscopic ultrasound-guided fine needle aspiration for small pancreatic cancer 10mm and additional salvage by pancreatic juice cytology |
| Date of disclosure of the study information | 2023/01/05 |
| Last modified on | 2023/01/05 15:11:13 |
* 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
Real diagnostic ability of endoscopic ultrasound-guided fine needle aspiration for small pancreatic cancer 10mm and additional salvage by pancreatic juice cytology
Acronym
Diagnostic ability of EUS-FNAB for small pancreatic cancer 10mm and additional salvage by pancreatic juice cytology
Scientific Title
Real diagnostic ability of endoscopic ultrasound-guided fine needle aspiration for small pancreatic cancer 10mm and additional salvage by pancreatic juice cytology
Scientific Title:Acronym
Diagnostic ability of EUS-FNAB for small pancreatic cancer 10mm and additional salvage by pancreatic juice cytology
Region
| Japan |
Condition
Condition
pancreatic tumor within 10mm in diameter
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Technical success and diagnostic rate of EUS-FNAB for pancreatic cancer within 10mm in diameter
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Technical success and diagnostic rate of EUS-FNAB for pancreatic cancer within 10mm in diameter
Key secondary outcomes
Additional diagnostic ability of pancreatic juice cytology
Procedure related factors affecting accurate EUS-FNAB diagnosis
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with pancreatic tumor within 10mm in diameter by EUS during study period.
Key exclusion criteria
patients with pancreatic tumors more than 10mm in diameter by EUS.
patients with pancreatic metastasis from the other organ cancer/pancreatic malignant lymphoma/nodules in pancreatic cystic lesion
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Sagami |
Organization
Department of Gastroenterology, Oita San-ai Medical Center, Oita, Japan
Department of Gastroenterology, Faculty of Medicine, Oita University, Oita, Japan
Division name
Department of Gastroenterology
Zip code
870-1151
Address
1213 Ichi, Oita, Oita, Japan
TEL
0975411311
sagami1985@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Sagami |
Organization
Oita San-ai Medical Center
Division name
Department of Gastroenterology
Zip code
8701151
Address
1213 Ichi, Oita, Japan
TEL
0975411311
Homepage URL
sagami1985@yahoo.co.jp
Sponsor or person
Institute
Oita San-ai Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital
Tenri Hospital
Kindai University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Oita San-ai Medical Center
Address
1213 Ichi, Oita, Oita
Tel
0975411311
sagami1985@yahoo.co.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
大分三愛メディカルセンター (大分)，東京都立駒込病院(東京都)，天理病院(奈良県)，近大病院(大阪府)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 05 | 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
| 2023 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 01 | Month | 05 | Day |
Last modified on
| 2023 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056908
