Evaluation of Endoscopic Ultrasound Shear Wave Elastography (EUS-SWE) for the Diagnosis of Pancreatic Adenocarcinoma. (EDEN)

April 17, 2024 updated by: GCS Ramsay Santé pour l'Enseignement et la Recherche
To assess the diagnostic accuracy of Shear Wave elastography (SWE) for the diagnosis of pancreatic adenocarcinoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Pancreatic adenocarcinoma (PA) is the most common tumor of the pancreas, representing more than 90% of all solid pancreatic neoplasia and 55% -73% of solid pancreatic masses.

Given its poor prognosis and the major therapeutic consequences, the discrimination between PA and other pancreatic solid lesions is mandatory. Endoscopic ultrasound (EUS) is admitted as the most sensitive imaging procedure for the detection and characterization of pancreatic tumors. Based on only endosonographic features, it remains difficult to differentiate PA from other solid masses, the specificity (Spe) and accuracy of EUS for the diagnosis of pancreatic tumor malignancy range from 53-69% and 72-83%, respectively. Over the last 15 years, endoscopic ultrasound fine needle aspiration (EUS-FNA) or more recently fine needle biopsy (EUS-FNB) has demonstrated its efficiency for tissue sampling and pathologic diagnosis of PA. Complementary techniques have been developed to increase the diagnostic performance of EUS. EUS-Elastography (EUS-E) is another EUS image enhancement technique, which rational based on the difference in elasticity between the tissues. There are two types of elastographies: strain elastography (SE) and shear wave elastography (SWE).

Several studies have demonstrated the utility of ultrasound SWE (US-SWE) for the differential diagnosis of lesions of the breast, thyroid, prostate and for detection of pancreatic fibrosis and chronic pancreatitis. However, to date, there is no data about the performance of EUS-SWE for the differential diagnosis of pancreatic solid lesions.

Study Type

Observational

Enrollment (Estimated)

130

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Lyon, France, 69008
        • Recruiting
        • Hôpital Jean Mermoz
        • Contact:
        • Principal Investigator:
          • Rodica Gincul

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patient with a solid pancreatic mass of indeterminate origin

Description

Inclusion Criteria:

  • Patient over 18 years of age
  • Patient with a solid pancreatic mass of indeterminate origin

Exclusion Criteria:

  • Patient with ASA score 4 or 5
  • Patient with contraindication to SonoVue injection
  • Protected patient : major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient with a solid pancreatic lesion of an undetermined nature
Diagnostic test: Endoscopic ultrasound
Diagnosis of pancreatic adenocarcinoma with endoscopic ultrasound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The negative predictive value (NPV) determined from shear wave elastography
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Investigators

  • Principal Investigator: Rodica GINCUL, Hôpital Jean Mermoz

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)

September 21, 2021

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 15, 2021

First Submitted That Met QC Criteria

April 15, 2021

First Posted (Actual)

April 20, 2021

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A02679-30

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

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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