UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044789 |
|---|---|
| Receipt number | R000050815 |
| Scientific Title | Endoscopic ultrasound characteristics of high-grade pancreatic intraepithelial neoplasia and 10mm pancreatic ductal adenocarcinoma; A multicenter comparative study of video analysis |
| Date of disclosure of the study information | 2021/07/08 |
| Last modified on | 2021/07/08 09:27:25 |
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Basic information
Public title
Multicenter retrospective study for clinical findings in early diagnosis of pancreatic cancer
Endoscopic ultrasound characteristics of high-grade pancreatic intraepithelial neoplasia and 10mm pancreatic ductal adenocarcinoma; A multicenter comparative study of video analysis
Acronym
Endoscopic ultrasound characteristics of high-grade pancreatic intraepithelial neoplasia and 10mm pancreatic ductal adenocarcinoma
Scientific Title
Endoscopic ultrasound characteristics of high-grade pancreatic intraepithelial neoplasia and 10mm pancreatic ductal adenocarcinoma; A multicenter comparative study of video analysis
Scientific Title:Acronym
Endoscopic ultrasound characteristics of high-grade pancreatic intraepithelial neoplasia and 10mm pancreatic ductal adenocarcinoma
Region
| Japan |
Condition
Condition
Pancreatic ductal adenocarcinoma ten millimeter or less in diameter
High-grade Pancreatic intraepithelial neoplasia (PanIN)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify EUS-signs which may be useful in differentiating PDAC 10mm or less in diameter (10mm-PDAC) and High-grade PanIN from non-malignant pancreatic duct irregularity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome is clarifying characteristic EUS-signs in diagnosis of high-grade PanIN, 10mm-PDAC, and non-malignant pancreatic duct irregularity.
Key secondary outcomes
Secondary outcome is to evaluate diagnostic performance of EUS-signs. In addition, intra- and inter-observer agreement of EUS-signs was also analyzed in blind review sessions.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with lesions which were histopathologically diagnosed from resected specimen of pancreas as high-grade PanIN without invasive cancer.
2. Patietnts with invasive PDAC 10mm or less in diameter (10mm-PDAC); whose diameter was calculated on histopathological specimen.
3. Patients with lesions which were strongly suspected as a high-grade PanIN lesion but with no evidence of high-grade PanIN or PDAC were also enrolled. In particular, the lesions that histopathologically diagnosed from resected specimen with no evidence of high-grade PanIN, or these with negative results on pancreatic juice cytology at least once and no change on various imaging modalities during more than 3 years follow-up period were defined as non-malignant lesions.
Key exclusion criteria
Patients with high-grade intraductal papillary mucinous neoplasm (IPMN), intraductal papillary mucinous carcinoma, and 10mm-PDAC which was treated by preoperative chemotherapy were excluded. In all lesions, the cases with technical difficulties with processing movie files were also excluded.
Target sample size
60
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 Gastroenterolgoy
Zip code
870-1151
Address
1213 Oaza Ichi, Oita, Oita, Japan
TEL
097-541-1311
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 Gastroenterolgoy
Zip code
870-1151
Address
1213 Oaza Ichi, Oita, Oita, Japan
TEL
097-541-1311
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
Department of Gastroenterology and Hepatology, Kindai University
Department of Gastroenterology, Tenri Hospital
Department of Gastroenterology, Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Oita San-ai Medical Center
Address
1213 Oaza Ichi, Oita, Oita, Japan
Tel
097-541-1311
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
| 2021 | Year | 07 | Month | 08 | 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
| 2020 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 07 | Month | 08 | Day |
Last modified on
| 2021 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050815
