EUS 3.0-Tesla MRCP trial
Phase 3
Recruiting
- Conditions
- choledocholithiasis
- Registration Number
- JPRN-jRCT1032220442
- Lead Sponsor
- Suzuki Masato
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method diagnostic accuracy
- Secondary Outcome Measures
Name Time Method sensitivity,specificity, positive predictive value, and negative predictive value<br>detection rate of choledocholithiasis in the second examination<br>sensitivity,specificity, positive predictive value, and negative predictive value in the whole exmination<br>adverse events