UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041143
Receipt number R000046965
Scientific Title 3D ultrasonography for intestinal fibrosis in Crohn's disease
Date of disclosure of the study information 2020/08/10
Last modified on 2024/02/10 18:50:29

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Basic information

Public title

Can 3D ultrasonography evaluate fibrosis in Crohn's disease

Acronym

3D ultrasonography for Crohn's disease

Scientific Title

3D ultrasonography for intestinal fibrosis in Crohn's disease

Scientific Title:Acronym

3D ultrasonography for Crohn's disease

Region

Japan


Condition

Condition

Crohn's disease

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Crohn's disease (CD) is an idiopathic, chronic entelitis with transmural inflammation that results in intestinal stricture. There are two types of stricture: inflammatory stricture caused by edema and fibrotic stricture caused by fibrosis. It is desirable to establish imaging studies. In the present study, we will investigate the association between ultrasonographic pamameters such as wall thickening, increased blood flow, tissue elasticity, and histopathological fingings (fibrosis, inflammation, edema), and immunological findings (angiogenesis, inflammatory cell infiltration, cytokines and growth factors).

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Primary outcome is to evaluate the usefulness of 3D ultrasound parameters (wall thickening, blood flow, and elasticity) as a method to differentiate between inflammatory and fibrotic stenoses that occur in Crohn's disease.

Key secondary outcomes

Secondary outcome is to explore the immunological abnormalities that cause fibrosis by monitoring the immune abnormalities that cause stenosis by ultrasound.


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

15 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with CD who undergo CD-related surgery or MR enterography

Key exclusion criteria

1. Lesions that did not undergo intestinal resection, such as strictureplasty
2. When the principal investigator considered not suitable.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Shintaro
Middle name Sagami
Last name Sagami

Organization

Kitasato University Kitasato Institute Hospital

Division name

Department of gastroenterology

Zip code

108-8642

Address

5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan

TEL

03-3444-6161

Email

sagami@insti.kitasato-u.ac.jp


Public contact

Name of contact person

1st name Shintaro
Middle name Sagami
Last name Sagami

Organization

Kitasato University Kitasato Institute Hospital

Division name

Center for Advanced IBD Research and Treatment

Zip code

108-8642

Address

5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan

TEL

03-3444-6161

Homepage URL


Email

sagami@insti.kitasato-u.ac.jp


Sponsor or person

Institute

Kitasato University Kitasato Institute Hospital

Institute

Department

Personal name



Funding Source

Organization

KAKEN: 20K16707

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Research Ethics Committee, Kitasato University Kitasato Research Institute Hospital

Address

5-9-1, Shirokane, Minato-ku, Tokyo 108-8642, Japan

Tel

03-3444-6161

Email

kenkyu@insti.kitasato-u.ac.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

2020 Year 08 Month 10 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


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

Open public recruiting

Date of protocol fixation

2020 Year 07 Month 20 Day

Date of IRB

2020 Year 08 Month 05 Day

Anticipated trial start date

2020 Year 08 Month 10 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Recruitment of target people: patients who receive Crohn's disease related-surgery or MR enterography in Kitasato University Kitasato Institute Hospital between 10th August 2018 and 31th Mar. 2024.


Management information

Registered date

2020 Year 07 Month 17 Day

Last modified on

2024 Year 02 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046965


Research Plan
Registered date File name
2024/02/10 研究計画書_3DUS_v3.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name