Endoscopic Ultrasound Elastography (Strain Ratio) and Fractal-based Quantitative Analysis for the Mediastinal and Abdominal Lymphadenopathies (Lymph/EUS/01)

Endoscopic ultrasound (EUS) and EUS-guided tissue acquisition (EUS-TA) are minimally invasive techniques to establish the benign or malignant nature of lymph nodes (LNs) with a very high accuracy. In particular, for mediastinal LNs, a meta-analysis underlined that EUS features alone are not enough to reach a good sensitivity and specificity, while EUS-TA showed a slightly high sensitivity (88% vs. 85%) and a significantly high specificity (96% vs. 85%) for diagnosing the cause of LN enlargement. Considering all sites, according to the meta-analysis of Xu and colleagues, the assessment of LNs by EUS-elastography is a useful tool in differentiating benign and malignant LNs, with a sensitivity of 88% and a specificity of 85%.

For lymphadenopathy of unknown origin, ESGE recommends performing EUS-TA (or alternatively endobronchial ultrasound [EBUS]-guided) if the patient management requires a pathological result and no superficial lymphadenopathy is easily accessible. Unfortunately, EUS-TA may sometimes be challenging or inconclusive, due to blood contamination or insufficient material.

EUS elastography (EUS-E) is a non-invasive ultrasound technique that measures the hardness of tissues. The level of hardness of region of interest (ROI) can be evaluated using qualitative scores and/or quantitative methods (strain ratio; SR).

To date, most of the studies on EUS-E have been carried out using the Hitachi ultrasound machine. In particular, Paterson performed a quantitative analysis considering as a pathological value cut-off, the SR ≥7.5 for EUS-E in the nodal staging of esophageal cancer. The study involved 53 LNs using cytology as gold standard: their data showed that EUS-E had a sensitivity of 83%, specificity of 96%, PPV of 95% and NPV of 86%.

Recently, a new compact ultrasound processor, EU-ME2 (Olympus SE & CO. KG, Hamburg, Germany) that includes an elastography software was developed although data regarding its application in LNs evaluation are still not available. The concept of fractal geometry as a tool for describing natural objects was originally introduced by Benoit Mandelbrot. A fractal can be considered as an irregularly shaped object and that can be divided into fragments, each of them representing a self-similar reduced copy of the whole. The hun body is an example of natural fractal, as many of its parts are characterized by features resembling the typical fractal nature. It has been demonstrated that fractal geometry can be used to efficiently evaluate the geometrical complexity of imaging patterns observed in oncology.

The investigators recently published a study on the role of EUS elastography and fractal based analysis in the differentiation of solid pancreatic lesions. However, data regarding the application of fractal analysis to evaluate lymphadenopathies are still not available.

Study Overview

• Status: Completed
• Conditions: Lymph Nodes
• Intervention / Treatment: Other: EUS-E

• Study Type: Observational
• Enrollment (Actual): 101

Contacts and Locations

Study Locations

• Italy
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Endoscopy Unit, Humanitas Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with enlarged mediastinal or abdominal lymph nodes detected by cross-sectional imaging and confirmed at EUS will be enrolled.

Description

Inclusion Criteria:

• patients with identified enlarged lymph nodes;
• patients >18 years old.

Exclusion Criteria:

• patients who decline to participate in the study
• patients with contraindication to the procedure

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Enlarged mediastinal or abdominal; Consecutive patients with enlarged mediastinal or abdominal detected by cross-sectional imaging and confirmed at EUS will be enrolled.	Other: EUS-E; EUS-E

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of quantitative EUS-E (strain ratio)	The primary aim of this study is to evaluate the accuracy of quantitative EUS-E (strain ratio) for the diagnosis of malignancy in enlarged lymph nodes.	24 Months

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2019
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphadenopathy
• Other Study ID Numbers: 2364

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No