Clinical trial · Observational
EUS Shear Wave for Solid Pancreatic Lesions.
Endoscopic Ultrasound Shear Wave for Neoplasia and Inflammation Assessment Among Solid Pancreas Lesions: a Case-control Observational Trial.
NCT05095831CI-TRIAL-00055785unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The diagnosis of pancreas diseases is based on a combination of clinical signs, symptoms, and laboratory tests, but mainly on imaging techniques such as computed tomography (CT) and magnetic resonance (MR). However, CT/MR have variable sensitivity and specificity, with certain disadvantages. Endoscopic ultrasound with elastography is an important resource with higher diagnostic accuracy in assessing solid pancreas lesions. Shear wave velocities of healthy parenchyma, acute, chronic and autoimmune pancreatitis, neoplastic lesions of the pancreas must be evaluated and compared.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreas Neoplasm | Pancreatic Neoplasm | ALIAS | 0.90 |
| Pancreatitis | — | UNRESOLVED | — |
| Pancreatitis, Acute | — | UNRESOLVED | — |
| Pancreatitis, Autoimmune | — | UNRESOLVED | — |
| Pancreatitis, Chronic | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pancreas EUS-elastography and EUS-guided biopsy | Diagnostic Test | — | UNRESOLVED |
| Pancreas EUS shear wave | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Suspicion of solid neoplastic lesion
- description
- Patients with high suspicion of solid pancreas neoplasia: carcinoma, intrapapillary mucinous neoplasia (IPMN), neuroendocrine tumor, lymphoma, or intrapancreatic metastasis; based on CT/MR.
- interventionNames
- Diagnostic Test: Pancreas EUS shear wave
- Diagnostic Test: Pancreas EUS-elastography and EUS-guided biopsy
- label
- Suspicion of a solid inflammatory lesion
- description
- Patients with high suspicion of solid inflammatory lesions: acute, chronic, or autoimmune pancreatitis; based on CT/MR.
- interventionNames
- Diagnostic Test: Pancreas EUS shear wave
- Diagnostic Test: Pancreas EUS-elastography and EUS-guided biopsy
- label
- Control group
- description
- Patients without a history of any type of solid or hematologic malignancy, hepato-pancreato-biliary disease (including fatty liver and pancreas disease), tobacco/alcohol habits, or morbid obesity with bariatric surgery criteria; who require EUS evaluation (e.g., suspicious of a subepithelial lesion in the context of chronic dyspepsia).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * Neoplasia group: high suspicion of pancreas neoplasia based on computed tomography and/or nuclear magnetic resonance. * Inflammatory group: high suspicion of acute or chronic pancreatitis based on computed tomography and/or nuclear magnetic resonance. * Control group: patients without a history of any type of solid or hematologic malignancy, hepato-pancreato-biliary disease (including fatty liver and pancreas disease), tobacco/alcohol habits, or morbid obesity with bariatric surgery criteria; who require EUS evaluation (e.g., suspicious of a subepithelial lesion in the context of chronic dyspepsia). Exclusion Criteria: * Uncontrolled coagulopathy, kidney/liver failure, or any comorbidity with important impact on cardiac risk assessment (NHYA III/IV); * Impossibility of EUS-guided biopsy (only for neoplasia or inflammatory group); * Pregnancy or nursing; * Refuse to participate in the study and/or to sign corresponding informed consent.
References
Publications (4)
- RESULTOkasha H, Elkholy S, El-Sayed R, Wifi MN, El-Nady M, El-Nabawi W, El-Dayem WA, Radwan MI, Farag A, El-Sherif Y, Al-Gemeie E, Salman A, El-Sherbiny M, El-Mazny A, Mahdy RE. Real time endoscopic ultrasound elastography and strain ratio in the diagnosis of solid pancreatic lesions. World J Gastroenterol. 2017 Aug 28;23(32):5962-5968. doi: 10.3748/wjg.v23.i32.5962. PMID 28932088
- RESULTBayramoglu Z, Akyol Sari ZN, Koker O, Adaletli I, Eker Omeroglu R. Shear wave elastography evaluation of liver, pancreas, spleen and kidneys in patients with familial mediterranean fever and amyloidosis. Br J Radiol. 2021 Dec;94(1128):20210237. doi: 10.1259/bjr.20210237. Epub 2021 Sep 14. PMID 34520686
- RESULTPlatz Batista da Silva N, Engesser M, Hackl C, Brunner S, Hornung M, Schlitt HJ, Evert K, Stroszczynski C, Jung EM. Intraoperative Characterization of Pancreatic Tumors Using Contrast-Enhanced Ultrasound and Shear Wave Elastography for Optimization of Surgical Strategies. J Ultrasound Med. 2021 Aug;40(8):1613-1625. doi: 10.1002/jum.15545. Epub 2020 Oct 30. PMID 33124700
- RESULTSuzuki H, Ishikawa T, Ohno E, Iida T, Uetsuki K, Yashika J, Yamada K, Yoshikawa M, Furukawa K, Nakamura M, Honda T, Ishigami M, Kawashima H, Fujishiro M. An initial trial of quantitative evaluation of autoimmune pancreatitis using shear wave elastography and shear wave dispersion in transabdominal ultrasound. Pancreatology. 2021 Jun;21(4):682-687. doi: 10.1016/j.pan.2021.02.014. Epub 2021 Feb 20. PMID 33648879