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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-21

Study Completion Date

2025-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pancreas Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient with a solid pancreatic lesion of an undetermined nature

Endoscopic ultrasound

Intervention Type DIAGNOSTIC_TEST

Diagnosis of pancreatic adenocarcinoma with endoscopic ultrasound.

Interventions

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Endoscopic ultrasound

Diagnosis of pancreatic adenocarcinoma with endoscopic ultrasound.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No