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A prospective randomized controlled trial comparing 22G and 25G Franseen needles for EUS-guided fine-needle biopsy sampling of solid pancreatic masses

A prospective randomized controlled trial comparing 22G and 25G Franseen needles for EUS-guided fine-needle biopsy sampling of solid pancreatic masses - A prospective randomized controlled trial comparing 22G and 25G Franseen needles for EUS-guided fine-needle biopsy sampling of solid pancreatic masses

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000034596
Enrollment
90
Registered
2018-10-22
Start date
2018-11-20
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

solid pancreatic masses

Interventions

In EUS-FNA, 1st puncture using 25-G Franseen needle and 2nd puncture using 22-G Franseen needle. In EUS-FNA, 1st puncture using 22-G Franseen needle and 2nd puncture using 25-G Franseen needle.

Sponsors

Okayama University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with solid pancreatic masses who are referred to EUS-FNA

Exclusion criteria

Exclusion criteria: 1)Patients with Performance status 4 2)Patients who have risk of bleeding, or with platelet count less than fifty thousand/mm2 3)Patients with anti-thrombotic agent 2 or more 4)Patients with pancreatic mass which we cannot detect by EUS 5)Pregnant woman 6)Patients less than 20 years old 7)Patients who do not agree to participate in this study 8)Patients who determined to be inappropriate

Design outcomes

Primary

MeasureTime frame
The tissue collection rate in each needle (cellularity score: 3,4,5)

Secondary

MeasureTime frame
1)Histological core collection rate in each needle(cellularity score: 5) 2)The tissue collection rate based on the tumor size, location, puncture rout and each pancreatic disease 3)Onsite diagnostic adequacy in each needle 4)Diagnostic accuracy in each needle 5)Specimen bloodiness in each needle 6)Ease of puncture in each needle 7)Needle visibility in each needle 8)Technical success rate in each needle 9)Adverse events

Countries

Japan

Contacts

Public ContactTakeshi Tomoda

Okayama University Hospital Department of Gastroenterology and Hepatology

tomotake79@yahoo.co.jp086-235-7219

Outcome results

None listed

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