UMIN-CTR Clinical Trial

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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