Diagnostic Accuracy of Eus Fnb in Difficult to Reach Lesions

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.

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Key information

Conditions

Hilar Cholangiocarcinoma Adenocarcinoma Carcinoma Cholangiocarcinoma Digestive System Diseases Digestive System Neoplasms Duodenal Diseases Duodenal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Klatskin Tumor Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A Gemelli IRCCS

Rome, RM, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

age ≥ 18 years;
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;
Patients monitored for at least 6 months after EUS-FNB or until death (follow-up less than 6 months);
Available data;
Written informed consent.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Diagnostic accuracy of eus fnb

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jun 2, 2026
Registry last updated: Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed