UMIN-CTR Clinical Trial

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
Institute	The Jikei University School of Medicine
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049388