Diagnostic Accuracy of Eus Fnb in Difficult to Reach Lesions

June 1, 2026 updated by: Spada Cristiano, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

131

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • RM
      • Rome, RM, Italy, 00168
        • Fondazione Policlinico Universitario A Gemelli IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Data on all the consecutive EUS performed for para-duodenal, para-jejunal land hepatic hilum lesions in our Unit between January 2013 and June 2023 will be retrospectively reviewed.

Telephone contact will be performed if additional information is required to fulfil the Case Report Forms (CRF). CRFs will be used to collect the data. CRFs are fully anonymized using a progressive alphanumeric identification code and the age instead of the date of birth. CRFs will be translated into an electronic spreadsheet.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 6 months after EUS-FNB, or at the time of surgical histopathologic diagnosis if surgery occurred earlier

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Cristiano Spada, Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Actual)

January 1, 2026

Study Completion (Actual)

February 1, 2026

Study Registration Dates

First Submitted

May 25, 2026

First Submitted That Met QC Criteria

June 1, 2026

First Posted (Actual)

June 2, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7859

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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