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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043346
Receipt No. 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 2021/02/17

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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
Email 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
Email kin_toshifumi@yahoo.co.jp

Sponsor
Institute Center for Gastroenterology, Teine-Keijinkai Hospital
Institute
Department

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
Email 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 No longer recruiting
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
2021 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049479

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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