UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049681 |
|---|---|
| Receipt number | R000056586 |
| Scientific Title | Comparison of surgical pathological diagnosis by pancreatic juice cytology and resected specimen in patients with intraductal papillary mucinous neoplasm (IPMN)-Multicenter study(Accompaniment study)- |
| Date of disclosure of the study information | 2022/12/05 |
| Last modified on | 2022/12/03 18:25:11 |
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Basic information
Public title
Comparison of surgical pathological diagnosis by pancreatic juice cytology and resected specimen in patients with intraductal papillary mucinous neoplasm (IPMN)-Multicenter study(Accompaniment study)-
Acronym
Comparison of surgical pathological diagnosis by pancreatic juice cytology and resected specimen in patients with intraductal papillary mucinous neoplasm (IPMN)-Multicenter study(Accompaniment study)-
Scientific Title
Comparison of surgical pathological diagnosis by pancreatic juice cytology and resected specimen in patients with intraductal papillary mucinous neoplasm (IPMN)-Multicenter study(Accompaniment study)-
Scientific Title:Acronym
Comparison of surgical pathological diagnosis by pancreatic juice cytology and resected specimen in patients with intraductal papillary mucinous neoplasm (IPMN)-Multicenter study(Accompaniment study)-
Region
| Japan |
Condition
Condition
Intraductal papillary mucinous neoplasm
Classification by specialty
| Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
By a multicenter study, we weigh final pathology after the resection against the preoperative pancreatic juice cytodiagnosis of the IPMN resection case, and this study is intended whether it can be a surgery adaptive predictor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnosability of the preoperative pancreatic juice cytodiagnosis of IPMN
Key secondary outcomes
Diagnosability of the pancreatic juice cytodiagnosis
Single variable, multivariable analysis of the factor contributing to a group by form, a site, intramural nodule diameter and the pancreatic duct diameter, T factor, diagnosability
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
(1) We conduct ERCP lower pancreatic juice cytodiagnosis before resection
Key exclusion criteria
(1)The case that a specimen of the pancreatic juice cytodiagnosis is insufficient, and an evaluation is difficult.
(2)A case with the coexistence pancreatic cancer.
(3)In addition, the case that a study responsibility physician or a study allotment physician judged to be inadequate.
Target sample size
850
Research contact person
Name of lead principal investigator
| 1st name | Toshiharu |
| Middle name | |
| Last name | Ueki |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Gastroenterology
Zip code
8188502
Address
1-1-1 Zokumyoin, Tikushino, Fukuoka
TEL
0929211011
tosiueki@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Rintaro |
| Middle name | |
| Last name | Ngayama |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Gastroenterology
Zip code
8188502
Address
1-1-1 Zokumyoin, Tikushino, Fukuoka
TEL
0929211011
Homepage URL
rn19810516@gmail.com
Sponsor or person
Institute
Aichi Cancer Hospital
Institute
Department
Personal name
Funding Source
Organization
Aichi Cancer Hospital
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
Fukuoka University Chikushi Hospital
Address
1-1-1 Zokumyoin, Tikushino, Fukuoka
Tel
0929211011
rn19810516@gmail.com
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
| 2022 | Year | 12 | 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
852
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We weigh preoperative ERCP lower pancreatic juice cytodiagnosis against pathological diagnosis after the IPMN resection and search for pancreatic juice cytodiagnosis tail diagnosability.
Management information
Registered date
| 2022 | Year | 12 | Month | 03 | Day |
Last modified on
| 2022 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056586
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
