UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043271
Receipt number R000049388
Scientific Title Pancreatobiliary Endoscopic Ultrasound training using novel assessment tool: A single center prospective cohort study
Date of disclosure of the study information 2021/02/07
Last modified on 2021/02/07 14:29:27

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Basic information

Public title

Pancreatobiliary Endoscopic Ultrasound training using novel assessment tool: A single center prospective cohort study

Acronym

Pancreatobiliary Endoscopic Ultrasound training using novel assessment tool: A single center prospective cohort study

Scientific Title

Pancreatobiliary Endoscopic Ultrasound training using novel assessment tool: A single center prospective cohort study

Scientific Title:Acronym

Pancreatobiliary EUS training using novel assessment tool: A single center prospective cohort study

Region

Japan


Condition

Condition

Pancreatobiliary disease

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Development of new objective assessment tool for pancreatobiliary EUS and definition of required procedure number and time to acquire the technique.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Development of new objective assessment tool for pancreatobiliary EUS

Key secondary outcomes

Definition of required procedure number and time to acquire the technique.


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients with biliary disorder or suspected by CT, MRI and/or US, who undergo pancreatobiliary EUS procedures.
2. Performance status; 0, 1, 2.
3. more than 20 years old
4. Patients who written informed consent to undergo EUS was obtained.

Key exclusion criteria

1. Patients with pregnancy or suspected, and patients during lactation.
2. Patients with mental disease.
3. Patients or patients'family who reject the participation in this study, when the opportunity to opt out of this study participation was also provided.
4. Patients who discontinue EUS procedures.

Target sample size

2400


Research contact person

Name of lead principal investigator

1st name Masafumi
Middle name
Last name Chiba

Organization

The Jikei University School of Medicine

Division name

Department of Endoscopy

Zip code

1058461

Address

3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo, Japan

TEL

03-3433-1111

Email

ccl09720@gmail.com


Public contact

Name of contact person

1st name Masafumi
Middle name
Last name Chiba

Organization

The Jikei University School of Medicine

Division name

Department of Endoscopy

Zip code

1058461

Address

3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo, Japan

TEL

03-3433-1111

Homepage URL


Email

ccl09720@gmail.com


Sponsor or person

Institute

The Jikei University School of Medicine

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

Human Subjects Committee of Jikei University School of Medicine

Address

3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo, Japan

Tel

+81 3 34331111, ext. 2134

Email

ccl09720@gmail.com


Secondary IDs

Secondary IDs

YES

Study ID_1

29-224(8840)

Org. issuing International ID_1

Human Subjects Committee of Jikei University School of Medicine

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

東京慈恵会医科大学附属病院


Other administrative information

Date of disclosure of the study information

2021 Year 02 Month 07 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

2017 Year 11 Month 14 Day

Date of IRB

2011 Year 11 Month 14 Day

Anticipated trial start date

2018 Year 01 Month 01 Day

Last follow-up date

2021 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

he present study is a prospective single-center cohort study including consecutive patients with suspected hepatobiliary-pancreatic disorders who underwent EUS attempts between January 1, 2018 and November 30, 2021.


Management information

Registered date

2021 Year 02 Month 07 Day

Last modified on

2021 Year 02 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049388


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name