Comparison of endoscopically guided tissue biopsy techniques

A prospective, randomized trial comparing novel FNB needle and popular FNB needle for EUS-guided tissue acquisition in solid pancreatic lesions

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0009576

Enrollment

124

Registered

2024-06-28

Start date

2024-08-22

Completion date

Unknown

Last updated

2026-04-20

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

Conditions

None listed

Interventions

Medical Device : The procedure order is randomly assigned, but each needle is applied to the first and second punctures. In other words, a total of two punctures are attempted for all patients. Group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Patients undergoing endoscopic ultrasound-guided tissue biopsy for histological diagnosis of pancreatic solid masses ? Men and women over 19 years of age

Exclusion criteria

Exclusion criteria: ? A cystic lesion containing only pure liquid components within the mass, without any solid components that may suggest malignancy. ? If you have a bleeding disorder or coagulation disorder (e.g. DIC), or if your platelet count is less than 50,000/mm3 or INR is more than 1.5. ? When anticoagulant treatment cannot be postponed ? In case of hemodynamic instability (e.g. shock) ? Women of childbearing potential who cannot use appropriate contraception or are pregnant

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy	—

Secondary

Measure	Time frame
Procurement rate of optimal histologic cores;Diagnostic yield: sensitivity, specificity, positive predict value, negative predict value	—

Countries

Korea, Republic of

Contacts

Public ContactSe Woo Park

Hallym University Medical Center-Dongtan

britnepak@outlook.com+82-31-8086-2858

Outcome results