The comparison of tissue acquisition for gastrointestinal subepithelial tumors of 2 cm or less with endoscopic ultrasound-guided fine-needles: A multicenter randomized controlled trial
Phase 3
Recruiting
- Conditions
- Submucosal epithelial lesion
- Registration Number
- JPRN-jRCTs052230144
- Lead Sponsor
- Kitano Masayuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
(1)Patients with suspected solid SELs of 2 cm or less on prior EUS
(2)Patients scheduled to undergo EUS-FNB
(3)Patients who are at least 18 years old at the time of consent
(4)Patients with ECOG performance status 2 or lower
(5)Patients who are able and willing to comply with study procedures and provide their own written consent to participate in the research
Exclusion Criteria
(1) Patients with bleeding tendency
(2) Patients with cystic SELs
(3) Pregnant or possibly pregnant patients
(4) Patients deemed by the principal investigator or sub-investigator to be unsuitable to participate in the research for any other reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of adequate specimen collection in the first puncture specimen
- Secondary Outcome Measures
Name Time Method (1)Percentage of successful punctures<br>(2)Percentage of procedures completed<br>(3)Percentage of procedural accidents<br>(4)GIST diagnostic performance (sensitivity, specificity, and positive diagnosis rate) in the first puncture specimen<br>(5)Number of punctures until white specimen collection by macroscopic on-site evaluation (MOSE)