Safety and utility of Endoscopic Ultrasound-guided Fine Needle Aspiration

Safety and utility of Endoscopic Ultrasound-guided Fine Needle Aspiration - Observational study of EUS-FNA

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000053924

Enrollment

3000

Registered

2024-03-21

Start date

2024-03-21

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

Patients who underwent EUS-FNA or interventional EUS

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients who underwent EUS-FNA or related procedures for definitive diagnosis at Fukushima Medical University Hospital and collaborating research institutions from January 2001 to December 2033.

Exclusion criteria

Exclusion criteria: All patients who decline to participate in the study.

Design outcomes

Primary

Measure	Time frame
Diagnostic ability	—

Secondary

Measure	Time frame
1. Specimen acquisition rate 2. Others a. Patient background (age, gender, medical history, presence of antithrombotic drug use, other medication history, lifestyle, current medical conditions, etc.) b. Imaging diagnosis (pre-EUS-FNA diagnosis, imaging findings from CT, MRI, US, EUS, endoscopy, etc.) c. Examination results (number of punctures, puncture routes, specimen acquisition rate, diagnostic accuracy, etc.) d. Submucosal tumors of the gastrointestinal tract: For GIST and neuroendocrine tumors (NET/NEC), the concordance rate of the MIB-1 index between FNA specimens and surgical specimens is also evaluated. e. Pancreatic tumors: Particularly, the diagnostic capability for typical pancreatic cancer, neuroendocrine tumors (NET/NEC), and autoimmune pancreatitis (AIP) is assessed. Additionally, for NET/NEC, the concordance rate of the MIB-1 index between FNA specimens and surgical specimens is also evaluated. f. Therapeutic outcomes related to EUS-guided biliary drainage or EUS-guided pancreatic cyst drainage, etc., associated with EUS-FNA. g. Incidental events (frequency of bleeding, perforation, infection, peritoneal seeding, etc., and their management) h. Clinical course after examination (surgery, chemotherapy, observation, etc.)	—

Measure

Time frame

1. Specimen acquisition rate 2. Others a. Patient background (age, gender, medical history, presence of antithrombotic drug use, other medication history, lifestyle, current medical conditions, etc.) b. Imaging diagnosis (pre-EUS-FNA diagnosis, imaging findings from CT, MRI, US, EUS, endoscopy, etc.) c. Examination results (number of punctures, puncture routes, specimen acquisition rate, diagnostic accuracy, etc.) d. Submucosal tumors of the gastrointestinal tract: For GIST and neuroendocrine tumors (NET/NEC), the concordance rate of the MIB-1 index between FNA specimens and surgical specimens is also evaluated. e. Pancreatic tumors: Particularly, the diagnostic capability for typical pancreatic cancer, neuroendocrine tumors (NET/NEC), and autoimmune pancreatitis (AIP) is assessed. Additionally, for NET/NEC, the concordance rate of the MIB-1 index between FNA specimens and surgical specimens is also evaluated. f. Therapeutic outcomes related to EUS-guided biliary drainage or EUS-guided pancreatic cyst drainage, etc., associated with EUS-FNA. g. Incidental events (frequency of bleeding, perforation, infection, peritoneal seeding, etc., and their management) h. Clinical course after examination (surgery, chemotherapy, observation, etc.)

—

Countries

Japan

Contacts

Public ContactRei Suzuki

Fukushima Medical University Department of Gastroenterology

subaru@fmu.ac.jp024-547-1202

Outcome results