UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043346 |
|---|---|
| Receipt number | R000049479 |
| Scientific Title | Comparison between CT and EUS in the detection of mural nodule accompanied with Intraductal papillary mucinous neoplasm between : retrospective multicenter study |
| Date of disclosure of the study information | 2021/02/17 |
| Last modified on | 2023/08/21 11:28:42 |
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Basic information
Public title
Comparison between CT and EUS in the detection of mural nodule accompanied with Intraductal papillary mucinous neoplasm between : retrospective multicenter study
Acronym
Comparative study between EUS and CT in the detention of mural nodule
Scientific Title
Comparison between CT and EUS in the detection of mural nodule accompanied with Intraductal papillary mucinous neoplasm between : retrospective multicenter study
Scientific Title:Acronym
Comparison between CT and EUS in the detection of mural nodule accompanied by Intraductal papillary mucinous neoplasm between : retrospective multicenter study
Region
| Japan |
Condition
Condition
intraductal papillary mucinous neoplasia(IPMN)
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the detection ability of mural nodule accompanied with IPMN
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of mural nodule accompanied with IPMN in imaging study
Key secondary outcomes
Detection rate of mural nodule according to pathological type
Detection rate of mural nodule according to the size
Chronological detection rate of mural nodule
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
Resected IPMN from January 1996 and December 2014
Confirmed mural nodule >1mm in pathological examination to resected specimen
Preoperative contrast enhanced CT and EUS evaluation
Key exclusion criteria
Absence of the pathological examination regarding mural nodule
Absence of contrast enhanced CT or EUS examination before surgical resection
Considered as inappropriate case for this study
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Toshifumi |
| Middle name | |
| Last name | Kin |
Organization
Teine-Keijinkai Hospital
Division name
Center for Gastroenterology
Zip code
006-8555
Address
1-40-1-12 Maeda, Teine-ku, Sapporo, Hokkaido
TEL
011-681-8111
kin_toshifumi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Toshifumi |
| Middle name | |
| Last name | Kin |
Organization
Teine-Keijinkai Hospital
Division name
Center for Gastroenterology
Zip code
006-8555
Address
1-40-1-12 Maeda, Teine-ku, Sapporo, Hokkaido
TEL
011-681-8111
Homepage URL
kin_toshifumi@yahoo.co.jp
Sponsor or person
Institute
Center for Gastroenterology, Teine-Keijinkai Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teine-Keijinkai Hospital
Address
1-40-1-12 Maeda, Teine-ku, Sapporo, Hokkaido
Tel
0116818111
tkgc@tb3.so-net.ne.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 | 02 | Month | 17 | 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
240
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
Main results already published
Date of protocol fixation
| 2019 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Detection rate of mural nodule accompanied with IPMN in imaging study
Detection rate of mural nodule according to pathological type
Detection rate of mural nodule according to the size
Chronological detection rate of mural nodule
Management information
Registered date
| 2021 | Year | 02 | Month | 17 | Day |
Last modified on
| 2023 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049479
