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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

A multicenter, randomized, controlled trial to compare tissue acquisition for gastrointestinal subepithelial tumors of 2 cm or less with endoscopic ultrasound-guided fine-needle - EUS-FNB for SELs

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052230144
Enrollment
110
Registered
2023-12-13
Start date
2024-01-04
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Submucosal epithelial lesion

Interventions

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

Sponsors

Kitano Masayuki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Percentage of adequate specimen collection in the first puncture specimen

Secondary

MeasureTime frame
(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)

Contacts

Public ContactYasunobu Yamashita

Wakayama Medical University Hospital

yasunobu@wakayama-med.ac.jp+81-73-447-2300

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026