A prospective study for comparing newly designed 21-gauge and standard 22-gauge aspiration needles for the diagnosis of solid pancreatic masses

A prospective study for comparing newly designed 21-gauge and standard 22-gauge aspiration needles for the diagnosis of solid pancreatic masses - Prospective study comparing 21-gaude and 22-gauge needles for EUS-FNA of pancreatic masses

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032598

Enrollment

100

Registered

2018-05-25

Start date

2014-06-01

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

solid pancreatic masses

Interventions

EUS-FNA is performed with a novel 21-gauge needle (EUS Sonopsy CY, Hakko Medical). EUS-FNA is performed with a standard 22-gauge needle (SonoTip ProControl, Medi-Globe GmbH)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with a solid pancreatic mass who are planned to EUS-FNA

Exclusion criteria

Exclusion criteria: 1. Patients with ECOG Performance status 4 2. Patients with bleeding tendency (prothrombin time international normalized ratio >1.5, platelets <50000) 3. Patients with pancreatic mass which cannot be visualized on EUS 4. Patients younger than 20 years old 5. Patients who do not agree to participate in this study

Design outcomes

Primary

Measure	Time frame
Comparison of diagnostic yield (sample cellularity and bloodiness) of the FNA samples between newly designed 21-gauge and standard 22-gauge needles for solid pancreatic masses	—

Secondary

Measure	Time frame
Comparison of technical success, diagnostic performance for malignancy, the number of needle passes required to obtain a diagnosis, needle angle during puncture, and complications	—

Countries

Japan

Contacts

Public ContactKosuke Minaga

Japanese Red Cross Wakayama Medical Center Department of Gastroenterology and Hepatology

kousukeminaga@yahoo.co.jp073-422-4171

Outcome results

None listed

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