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Comparison of Dual-bevel raptor tip needle verses Franseen needle in EUS-TA for pancreatic mass

Comparison of Dual-bevel raptor tip needle verses Franseen needle in EUS-guided tissue acquisition for pancreatic mass - RAPAN study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1042250151
Enrollment
220
Registered
2025-12-23
Start date
2026-01-01
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

pancreatic mass pancreatic mass

Interventions

Patients with pancreatic masses will be randomly assigned in a 1:1 ratio to undergo endoscopic ultrasound-guided tissue acquisition (EUS-TA) using either a dual-beveled raptor tip needle or a Franseen
D004717, D001982
endoscopic ultrasound-guided tissue acquisition, EUS-TA, dual-beveled raptor tip needle

Sponsors

Murabayashi Toji
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with pancreatic masses identified on imaging studies (CT, MRI, abdominal ultrasonography, or endoscopic ultrasonography) who are scheduled to undergo endoscopic ultrasound-guided tissue acquisition (EUS-TA).

Exclusion criteria

Exclusion criteria: 1. Patients with a prior pathological diagnosis of pancreatic cancer who undergo endoscopic ultrasound-guided EUS-TA solely for the purpose of comprehensive cancer genomic profiling. 2. Inability to visualize the pancreatic mass by endoscopic ultrasonography due to anatomical reasons. 3. Lesions deemed not amenable to needle puncture based on imaging studies. 4. Bleeding tendency, defined as a prothrombin time-international normalized ratio (PT-INR) > 1.5 or a platelet count < 50000/mm3. 5. Inability to discontinue two or more antithrombotic agents. 6. Age < 18 years. 7. Pregnancy.

Design outcomes

Primary

MeasureTime frame
Pathological diagnostic accuracy

Secondary

MeasureTime frame
1. Technical success rate 2. Difficulty of needle puncture 3. Procedure-related adverse events 4. Macroscopic quantity and quality of the obtained specimen 5. Histological tissue quantity 6. Histological tumor tissue quantity

Contacts

Public ContactToji Murabayashi

Ise Red Cross Hospital

murabayashitoji@m2.gmobb.jp+81-596-28-2171

Outcome results

None listed

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