Diagnostic Accuracy of Eus Fnb in Difficult to Reach Lesions

Diagnostic Accuracy of Endoscopic Ultrasound-guided Fine Needle Biopsy in Assessing "Difficult-to-reach" Abdominal Lesions: an Observational, Retrospective Cohort Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07621536

Enrollment

131

Registered

2026-06-02

Start date

2025-10-01

Completion date

2026-02-01

Last updated

2026-06-02

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

Conditions

Duodenal Neoplasms, Hilar Cholangiocarcinoma

Brief summary

The present study aims at comprehensively assessing the diagnostic performance and safety profile of EUS-FNB as a primary diagnostic tool for suspected malignancies in anatomically complex or deeply situated regions, including the duodeno-jejunal, and hepatic hilar areas. By focusing on lesions that are challenging to reach due to their intricate anatomy or profound depth, investigators seek to provide valuable insights into the potential role of EUS-FNB in enhancing diagnostic accuracy and safety in these complex clinical scenarios.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. age ≥ 18 years; 2. patients with one or multiple lesions adjacent to the distal duodenum, or the proximal jejunum, or the hepatic hilum that underwent EUS in our Institution over the past 10 years; 3. Patients monitored for at least 6 months after EUS-FNB or until death (follow-up less than 6 months); 4. Available data; 5. Written informed consent.

Exclusion criteria

1. Age less than 18 years old; 2. Patient unable to sign the informed consent.

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic accuracy of eus fnb	At 6 months after EUS-FNB, or at the time of surgical histopathologic diagnosis if surgery occurred earlier	Diagnostic accuracy, calculated according to the formula = (true positives + true negatives) / (true positives + false positives + true negatives + false negatives), of EUS-FNB for all the difficult-to-detect abdominal lesions.

Countries

Italy

Contacts

PRINCIPAL_INVESTIGATORCristiano Spada, Professor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome results