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Lymph NodesLymph/EUS/01NCT04671784

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

An observational study of Lymph Nodes, run by Istituto Clinico Humanitas at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymph Nodes
What is being tested?
EUS-E
How many people
101 participants
Where
1 siteItaly
Study dates
27 Sep 2019to 30 Sep 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Endoscopy Unit, Humanitas Research Hospital

    Rozzano, Milano, 20089

Other trials in Italy

About this study

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.

Read more

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.

Conditions
Lymph Nodes
Being tested
EUS-E

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EUS-EOther

    EUS-E

Study groups in NCT04671784
Study groupRoleWhat they receive
Enlarged mediastinal or abdominalConsecutive patients with enlarged mediastinal or abdominal detected by cross-sectional imaging and confirmed at EUS will be enrolled.
Receives: Other: EUS-E

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start27 Sep 2019
  3. Primary completion30 Sep 2023
  4. Study completion30 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04671784
Sponsor's protocol ID
2364
Acronym
Lymph/EUS/01
Status last verified
Jul 2025
First submitted
7 Dec 2020
Last updated
30 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lymph Nodes, run by Istituto Clinico Humanitas at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of quantitative EUS-E (strain ratio) (time frame: 24 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.

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