High and normal negative pressure for endoscopic ultrasound-guided fine-needle aspiration using the 20-gauge side-port fine-needle aspiration needle in patients with pancreatic solid masses: A multicenter prospective randomized controlled study

High and normal negative pressure for endoscopic ultrasound-guided fine-needle aspiration using the 20-gauge side-port fine-needle aspiration needle in patients with pancreatic solid masses: A multicenter prospective randomized controlled study - High and normal negative pressure for EUS-FNA using the 20-gauge side-port fine-needle in pancreatic solid masses: A multicenter prospective randomized controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024508

Enrollment

110

Registered

2016-10-20

Start date

2016-07-16

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 solid mass

Interventions

Negative pressure for EUS-FNA (10mL) Negative pressure for EUS-FNA (50mL)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Diagnosed as pancreatic solid mass 2) Mass size of larger than 20mm 3) Age older than 20 4)Informed consent provided the patient him/herself

Exclusion criteria

Exclusion criteria: 1) Case of Performance Status 4. 2) Case with severe comorbidity; American Society of Anesthesiologists (ASA) Grade 3-5 3) Can not stop anti-coagulation or anti-platelet agents. 4) Pregnant or suspicious for pregnancy. 5) Difficulty with endoscopic approach due to post operative state. 6) Case with pathologically confirmation. 7) Gastrointestinal obstruction. 8) Platelet count less than 50,000/mm3 9) PT-INR more than 2.0 10) Those inadequate for endoscopy. 11) Those judged inappropriate by the doctors in charge.

Design outcomes

Primary

Measure	Time frame
Acquisition rate of tissue sample adequate for histological diagnosis	—

Secondary

Measure	Time frame
Acquisition rate of white tissue sample, accuracy of pathological diagnosis, size of the sample, adequacy for immunohistochemistry, quality of the sample, adequacy for cytologic diagnosis, and adverse events regarding puncturing site.	—

Countries

Japan

Contacts

Public ContactYoshimasa Kubota

University of Miyazaki Department of Gastroenterology and Hepatology

y_kubota@med.miyazaki-u.ac.jp0985-85-9797

Outcome results

None listed

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