UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052193 |
|---|---|
| Receipt number | R000058725 |
| Scientific Title | Additional impact of pancreatic juice cytology via endoscopic nasal pancreatic tube for the diagnosis of high-grade pancreatic intraepithelial neoplasia/ invasive pancreatic cancer without visible tumor by endoscopic ultrasound |
| Date of disclosure of the study information | 2023/09/13 |
| Last modified on | 2023/09/13 14:18:14 |
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Basic information
Public title
Additional impact of pancreatic juice cytology via endoscopic nasal pancreatic tube for the diagnosis of high-grade pancreatic intraepithelial neoplasia/ invasive pancreatic cancer without visible tumor by endoscopic ultrasound
Acronym
Usefulness of pancreatic juice cytology via endoscopic nasal pancreatic tube for the diagnosis of early pancreatic cancer
Scientific Title
Additional impact of pancreatic juice cytology via endoscopic nasal pancreatic tube for the diagnosis of high-grade pancreatic intraepithelial neoplasia/ invasive pancreatic cancer without visible tumor by endoscopic ultrasound
Scientific Title:Acronym
Usefulness of pancreatic juice cytology via endoscopic nasal pancreatic tube for the diagnosis of early pancreatic cancer
Region
| Japan |
Condition
Condition
high-grade pancreatic intraepithelial neoplasia/ invasive pancreatic cancer without visible tumor by endoscopic ultrasound
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of pancreatic juice cytology via endoscopic nasal pancreatic tube for the diagnosis of high-grade pancreatic intraepithelial neoplasia/ invasive pancreatic cancer without visible tumor by endoscopic ultrasound
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of sensitivity, spesificity, accuracy, and area under curve of pancreatic juice cytology via endoscopic nasal pancreatic tube and those of single pancreatic juice cytology during endoscopic retrograde pancreatography.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
pancreatic juice cytology for patients with highly suspected small pancreatic cancer without visible mass by endoscopic ultrasound from May 2015 to April 2023.
Key exclusion criteria
First, PJC for the diagnosis of suspected intraductal papillary mucinous neoplasm (IPMN) with high-grade dysplasia/carcinoma derive from IPMN was excluded because of the different nature of tumor. PJC for suspected PDAC with visible mass by EUS due to the failure diagnosis of EUS-FNAB was also excluded.
Patients with PJC positive results who underwent imaging follow-up less than one year without surgical resection and patients with PJC negative results who underwent imaging follow-up less than five years without surgical resection were excluded as undiagnosed cases, considering the progress nature/period of HG-PanIN and invasive PDAC.
Target sample size
22
Research contact person
Name of lead principal investigator
| 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, 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, 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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Oita San-ai Medical Center
Address
1213 Ichi, Oita, Oita, Japan
Tel
1975411311
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 13 | 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 | 06 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None declared
Management information
Registered date
| 2023 | Year | 09 | Month | 13 | Day |
Last modified on
| 2023 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058725
