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

JRCT ID: jRCTs052230144

Registered date:13/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Submucosal epithelial lesion
• Date of first enrollment: 04/01/2024
• Target sample size: 110
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• 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)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kitano Masayuki