Clinical trial · Observational
Clinical Impact of EUS Elastography Mean Strain Histograms (SH) and Contrast Peak-enhancement in Focal Pancreatic Masses and Lymph Nodes
Real-time Semi-quantification of Endoscopic Ultrasound Elastography and Contrast-enhancement Using Strain Histograms (SH) and Contrast-enhancement (CE) for the Differentiation of Focal Pancreatic Masses and the Assessment of Lymph Node Involvement
- 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 study protocol is based on a multi-center semi-quantitative approach of EUS elastography data in combination with contrast-enhanced EUS, consisting of measuring SR and SH for focal pancreatic masses and lymph nodes, as well as several parameters of CE-EUS based on time-intensity-curve (TIC) analysis. A number of parameters must be taken into consideration, as the ROIs are still manually selected by the user. The aim of the study is to establish an EUS based diagnostic algorithm in patients with pancreatic masses and lymph nodes, with negative or inconclusive cytopathology after EUS-FNA, based on previously published results and cut-offs of elastography and contrast-enhancement. The proposed algorithm of sequential use of real-time elastography, followed by contrast-enhanced EUS could be a good clinical tool to help select the patients with possible pancreatic adenocarcinoma or malignant lymph nodes, in the setting of patients with negative EUS-FNA results.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Neoplasm of Lymph Nodes | — | UNRESOLVED | — |
| Benign Pancreatic Tumors | Benign Pancreatic Neoplasm | ALIAS | 0.90 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Secondary Malignant Neoplasm of Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Elastography, contrast enhancement | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Pancreatic cancer
- description
- Consecutively admitted patients with pancreatic cancer confirmed by EUS-guided FNA. EG-EUS and CE-EUS will be applied in all patients.
- interventionNames
- Other: Elastography, contrast enhancement
- label
- Benign pancreatic masses
- description
- Consecutively admitted patients with benign pancreatic masses with negative EUS-guided FNA. EG-EUS and CE-EUS will be applied in all patients.
- interventionNames
- Other: Elastography, contrast enhancement
- label
- Malignant lymph nodes
- description
- Consecutively admitted patients with malignant lymphnodes confirmed by EUS-guided FNA. EG-EUS will be applied in all patients.
- interventionNames
- Other: Elastography, contrast enhancement
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with solid pancreatic tumor masses, with cytological / histo-logical confirmation * Patients with or without suspected lymph node involvement are eligible * Age 18 to 90 years old, men or women * Signed informed consent for EG-EUS, CE-EUS and FNA biopsy Exclusion Criteria: * Prior surgical treatment with curative intent or chemo-radiotherapy * Patients diagnosed with mucin producing tumors, pancreatic cystic tumors, etc.
References
Publications (36)
- BACKGROUNDGheonea DI, Saftoiu A. Beyond conventional endoscopic ultrasound: elastography, contrast enhancement and hybrid techniques. Curr Opin Gastroenterol. 2011 Sep;27(5):423-9. doi: 10.1097/MOG.0b013e328349cfab. PMID 21844751
- BACKGROUNDFrey H. [Realtime elastography. A new ultrasound procedure for the reconstruction of tissue elasticity]. Radiologe. 2003 Oct;43(10):850-5. doi: 10.1007/s00117-003-0943-2. German. PMID 14605701
- BACKGROUNDGarra BS, Cespedes EI, Ophir J, Spratt SR, Zuurbier RA, Magnant CM, Pennanen MF. Elastography of breast lesions: initial clinical results. Radiology. 1997 Jan;202(1):79-86. doi: 10.1148/radiology.202.1.8988195. PMID 8988195
- BACKGROUNDHavre RF, Waage JER, Gilja OH, Ødegaard S, Nesje LB. Semi-quantification of elastic contrasts by strain ratio in elastography - possibilities and pitfalls. Euroson 2010, Copenhagen August 22 - 25th
- BACKGROUNDOphir J, Alam SK, Garra B, Kallel F, Konofagou E, Krouskop T, Varghese T. Elastography: ultrasonic estimation and imaging of the elastic properties of tissues. Proc Inst Mech Eng H. 1999;213(3):203-33. doi: 10.1243/0954411991534933. PMID 10420776
- BACKGROUNDShiina T, Nitta N, Ueno E, Bamber JC. Real time tissue elasticity imaging using the combined autocorrelation method. J Med Ultrason (2001). 2002 Sep;29(3):119-28. doi: 10.1007/BF02481234. PMID 27277886
- BACKGROUNDItoh A, Ueno E, Tohno E, Kamma H, Takahashi H, Shiina T, Yamakawa M, Matsumura T. Breast disease: clinical application of US elastography for diagnosis. Radiology. 2006 May;239(2):341-50. doi: 10.1148/radiol.2391041676. Epub 2006 Feb 16. PMID 16484352
- BACKGROUNDMiyanaga N, Akaza H, Yamakawa M, Oikawa T, Sekido N, Hinotsu S, Kawai K, Shimazui T, Shiina T. Tissue elasticity imaging for diagnosis of prostate cancer: a preliminary report. Int J Urol. 2006 Dec;13(12):1514-8. doi: 10.1111/j.1442-2042.2006.01612.x.