臨床研究等提出・公開システム

Japanese

Date of registration	Nov. 07, 2022
Last modified on	May. 23, 2025
Trial ID	jRCT1032220442

Scientific Title	Endoscopic ultrasound versus 3.0-Tesla magnetic resonance cholangiopancreatography for the diagnosis of computed tomography-negative common bile duct stone: randomized controlled trial
Public Title	EUS 3.0-Tesla MRCP trial

Contact for Scientific Queries	Name	Suzuki Masato
	Affiliation	National Hospital Organization Yokohama Medical Center
	Address	3 Chome-60-2 Harajuku, Totsuka Ward, Yokohama, Kanagawa
	Telephone	+81-45-851-2621
	E-mail	d07sm056@gmail.com
Contact for Public Queries	Name	Suzuki Masato
	Affiliation	National Hospital Organization Yokohama Medical Center
	Address	3 Chome-60-2 Harajuku, Totsuka Ward, Yokohama, Kanagawa
	Telephone	+81-45-851-2621
	E-mail	d07sm056@gmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Nov. 07, 2022
Actual date of first enrollment		Nov. 22, 2022
Target sample size		90
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1)20 years of age or older. 2)Met the diagnostic criteria for suspected or definite acute cholangitis of mild or moderate severity according to TG18 despite negative CT results for choledocholithiasis. 3)Provided written informed consent.
	Exclusion Criteria	1)Patients with claustrophobia. 2)Patients with non-MRI compatible metal implants. 3)Patients who have an altered or postsurgical upper gastrointestinal anatomy. 4)Pregnant or lactating women. 5)Patients with severe acute cholangitis as per the TG18 guideline. 6)Patients otherwise deemed unfit by the investigators based on their clinical judgment.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		choledocholithiasis
Intervention(s)		MRCP group:undergo 3.0-Tesla MRCP EUS group:undergo EUS
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		diagnostic accuracy
Secondary Outcome(s)		sensitivity,specificity, positive predictive value, and negative predictive value detection rate of choledocholithiasis in the second examination sensitivity,specificity, positive predictive value, and negative predictive value in the whole exmination adverse events

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Yokohama Medical Center Ethics Review Committe
Address	3 Chome-60-2 Harajuku, Totsuka Ward, Yokohama, Kanagawa, Kanagawa
Telephone	+81-45-474-8111
E-Mail	d07sm056@gmail.com
Approval Status	Approval
Date of approval	Oct. 12, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	May. 23, 2025	(this page)	Changes
3	April. 10, 2023	Detail	Changes
2	Nov. 29, 2022	Detail	Changes
1	Nov. 07, 2022	Detail

List of change history