An interventional study of EUS shear wave and EUS-FNB in Pancreatic Cancer, Solid Pancreatic Mass Lesions and Pancreatic Adenocarcinoma, sponsored by Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor. Completed at 1 site in Romania. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor · Not applicable, Interventional, and Diagnostic
The aim of this prospective study is to evaluate the diagnostic accuracy of endoscopic ultrasound-guided shear wave elastography (EUS-SWE) in patients with solid pancreatic lesions. During a clinically indicated EUS with fine-needle biopsy, tissue stiffness will be measured by shear wave elastography in the pancreatic lesion and in the adjacent normal pancreatic parenchyma. Elastography values will be compared with the final cytological/histological diagnosis in order to assess the ability of EUS-SWE to differentiate malignant from benign lesions and to correlate stiffness with histological findings.
Elastography is a non-invasive imaging method for assessing tissue stiffness. Strain elastography provides qualitative/semi-quantitative information but depends on operator-applied pressure. Shear wave elastography (SWE) uses an acoustic radiation force impulse generated by the transducer to produce shear waves, allowing quantitative stiffness measurements. Transabdominal elastography of the pancreas is limited by the deep anatomical location of the organ; EUS-guided SWE overcomes this limitation.
Consecutive adult patients referred to the Regional Institute of Gastroenterology and Hepatology Cluj-Napoca with a solid pancreatic lesion confirmed or suspected on transabdominal ultrasound, CT or MRI will be enrolled after signing informed consent.
Procedure: EUS will be performed under sedation using an Olympus linear echoendoscope connected to a Canon Aplio i800 ultrasound system with shear wave elastography capability. After identification of the target lesion, SWE measurements will be obtained within the lesion and in the normal pancreatic parenchyma, followed by EUS-guided fine-needle biopsy as per standard of care. SWE measurements are expected to prolong the procedure by approximately 4 minutes.
Safety: patients will be monitored for at least 24 hours after the procedure (vital signs, blood count, CRP, amylase, lipase within 12 hours, abdominal ultrasound within 24 hours). Adverse events up to 7 days after the procedure will be recorded.
Reference standard: final diagnosis based on EUS-FNB cytology/histology, surgical histology when available, or clinical and imaging follow-up.
Statistical analysis: continuous variables will be reported as mean ± SD or median (IQR), categorical variables as counts and percentages. Diagnostic performance (sensitivity, specificity, PPV, NPV, accuracy) and ROC curve analysis with optimal cut-off determination will be calculated using IBM SPSS Statistics.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.
This study's enrollment of 62 is above the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Quantitative shear wave elastography measurements (kPa and/or m/s) of the pancreatic lesion and normal pancreatic parenchyma using a Canon Aplio i800 system with an Olympus linear echoendoscope.
Diagnostic Test: EUS shear wave · Diagnostic Test: EUS-FNB
Quantitative shear wave elastography measurements (kPa and/or m/s) of the pancreatic lesion and normal pancreatic parenchyma using a Canon Aplio i800 system with an Olympus linear echoendoscope.
Standard-of-care tissue acquisition for cytological/histological diagnosis
Diagnostic accuracy of EUS-SWE for differentiating malignant from benign solid pancreatic lesions
Sensitivity, specificity, PPV, NPV, overall accuracy and area under the ROC curve of SWE stiffness values, using the final diagnosis as reference standard.
Time frame: At final diagnosis, up to 6 months after EUS
Stiffness of solid pancreatic lesions versus normal pancreatic parenchyma
Comparison of stiffness values across histological diagnoses (e.g. adenocarcinoma, neuroendocrine tumor, focal pancreatitis, other).
Time frame: At final diagnosis, up to 6 months after EUS
Correlation between SWE values and histological type of the lesion
Comparison of stiffness values across histological diagnoses (e.g. adenocarcinoma, neuroendocrine tumor, focal pancreatitis, other).
Time frame: At final diagnosis, up to 6 months after EUS
Plan to share: No — Individual participant data will not be shared; aggregated results will be published.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor