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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name