EUS 3.0-Tesla MRCP trial

JRCT ID: jRCT1032220442

Registered date:07/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: choledocholithiasis
• Date of first enrollment: 22/11/2022
• Target sample size: 90
• Study type: Interventional

Intervention(s)

MRCP group:undergo 3.0-Tesla MRCP
EUS group:undergo EUS

Outcome(s)

• Primary Outcome: diagnostic accuracy

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Suzuki Masato