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UMIN ID: UMIN000053924

Registered date:21/03/2024

Safety and utility of Endoscopic Ultrasound-guided Fine Needle Aspiration

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Patients who underwent EUS-FNA or interventional EUS
Date of first enrollment	2024/03/21
Target sample size	3000
Countries of recruitment	Japan
Study type	Observational
Intervention(s)

TO Original Data: UMIN

Outcome(s)

Primary Outcome	Diagnostic ability
Secondary Outcome	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.)

Primary Outcome

Diagnostic ability

Secondary Outcome

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.)

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude criteria	All patients who decline to participate in the study.

Related Information

Primary Sponsor	Fukushima Medical University
Secondary Sponsor	Fukushima Rosai Hospital, Fukushima Red Cross Hospital, Soma General Hospital
Source(s) of Monetary Support	Fukushima Medical University
Secondary ID(s)

Contact

public contact
Name	Rei Suzuki
Address	1 Hikarigaoka, Fukushima, Japan Japan 960-1295
Telephone	024-547-1202
E-mail	subaru@fmu.ac.jp
Affiliation	Fukushima Medical University Department of Gastroenterology
scientific contact
Name	Rei Suzuki
Address	1 Hikarigaoka, Fukushima, Japan Japan
Telephone	024-547-1202
E-mail	subaru@fmu.ac.jp
Affiliation	Fukushima Medical University Department of Gastroenterology

TO Original Data: UMIN