Pancreas CancerEDENNCT04851106
Evaluation of Endoscopic Ultrasound Shear Wave Elastography (EUS-SWE) for the Diagnosis of Pancreatic Adenocarcinoma.
An observational study of Pancreas Cancer, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
To assess the diagnostic accuracy of Shear Wave elastography (SWE) for the diagnosis of pancreatic adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- Endoscopic ultrasound
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 29 Apr 2021to 31 Dec 2025
- 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: Patient with a solid pancreatic mass of indeterminate origin
Who may be able to join
- Patient over 18 years of age
- Patient with a solid pancreatic mass of indeterminate origin
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
To assess the diagnostic accuracy of Shear Wave elastography (SWE) for the diagnosis of pancreatic adenocarcinoma.
Read the 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.
- Conditions
- Pancreas Cancer
- Being tested
- Endoscopic ultrasound
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasoundDiagnostic test
Diagnosis of pancreatic adenocarcinoma with endoscopic ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Patient with a solid pancreatic lesion of an undetermined nature | Patient with a solid pancreatic lesion of an undetermined nature Receives: Diagnostic Test: Endoscopic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The negative predictive value (NPV) determined from shear wave elastography
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start29 Apr 2021
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 130 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rodica GINCUL, Principal investigator, Hôpital Jean Mermoz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851106
- Sponsor's protocol ID
- 2020-A02679-30
- Acronym
- EDEN
- Status last verified
- Aug 2026
- First submitted
- 15 Apr 2021
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Endoscopic Ultrasound Shear Wave Elastography (EUS-SWE) for the Diagnosis of Pancreatic Adenocarcinoma.
- ClinicalTrials.gov ID
- NCT04851106
- Acronym / sponsor ID
- EDEN / 2020-A02679-30
- Conditions
- Pancreas Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with a solid pancreatic lesion of an undetermined nature | – | Diagnostic Test: Endoscopic ultrasoundPatient with a solid pancreatic lesion of an undetermined nature |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with a solid pancreatic mass of indeterminate origin
Key inclusion criteria (2 listed)
- Patient over 18 years of age
- Patient with a solid pancreatic mass of indeterminate origin
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic ultrasoundDiagnosis of pancreatic adenocarcinoma with endoscopic ultrasound. | Diagnostic test | Patient with a solid pancreatic lesion of an undetermined nature |
Primary outcome
The negative predictive value (NPV) determined from shear wave elastography
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodica GINCUL principal investigator
Hôpital Jean Mermoz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Cancer, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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 3 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 20 Aug 2026. 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 France. 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?
The negative predictive value (NPV) determined from shear wave elastography (time frame: 12 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 20 Aug 2026.