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

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2023
INTERVENTION: Eligible patients with suspected substantial SELs of 2 cm or less on endoscopic ultrasonography performed prior to study participation and scheduled for EUS‐FNB for diagnosis will be enrolled in the study. After enrollment, patients will be randomly assigned to the Franseen needle 22G Fork‐tip needle or group for EUS‐FNB procedure. Then, on the day of the test procedure, the test procedure will be performed using the assigned puncture needle, and pathological diagnosis will be performed with punctured specimens. CONDITION: Submucosal epithelial lesion PRIMARY OUTCOME: Percentage of adequate specimen collection in the first puncture specimen SECONDARY OUTCOME: (1)Percentage of successful punctures; (2)Percentage of procedures completed; (3)Percentage of procedural accidents; (4)GIST diagnostic performance (sensitivity, specificity, and positive diagnosis rate) in the first puncture specimen; (5)Number of punctures until white specimen collection by macroscopic on‐site evaluation (MOSE) 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
Epistemonikos ID: 3cd03e63f0fb1fe660332b1f1179c390bb4e75e2
First added on: Aug 28, 2024