Diagnostic Accuracy of Eus Fnb in Difficult to Reach Lesions

NCT07621536 | Completed

• 1 other identifier: 7859
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Hilar Cholangiocarcinoma; Duodenal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of eus fnb

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A Gemelli IRCCS

Rome, RM, 00168, Italy

Location

MeSH Terms

Conditions

Klatskin Tumor; Duodenal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Cristiano Spada, Professor

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 2, 2026
• Study Start: October 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)