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Clinical Trials/NCT04851106
NCT04851106
Recruiting
Not Applicable

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

GCS Ramsay Santé pour l'Enseignement et la Recherche1 site in 1 country130 target enrollmentSeptember 21, 2021
ConditionsPancreas Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pancreas Cancer
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
Enrollment
130
Locations
1
Primary Endpoint
The negative predictive value (NPV) determined from shear wave elastography
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

To assess the diagnostic accuracy of Shear Wave elastography (SWE) for the diagnosis of pancreatic adenocarcinoma.

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.

Registry
clinicaltrials.gov
Start Date
September 21, 2021
End Date
December 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

The negative predictive value (NPV) determined from shear wave elastography

Time Frame: 12 months

Study Sites (1)

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