Clinical trial · Interventional
Usefulness of Contrast Enhanced Harmonic Endoscopic Ultrasound for Pancreatic Cysts
Usefulness of Contrast-enhanced Harmonic Endoscopic Ultrasound (CH-EUS) for the Differentiation of the Pancreatic Cysts and for Guiding Endoscopic Ultrasound Guided Fine Needle Aspiration (EUS-FNA) From Murale Nodules.
NCT04389892CI-TRIAL-00059229completedN/AClinicalTrials.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 study evaluates the role of contrast-enhanced harmonic endoscopic ultrasound (CH-EUS) for the differentiation of the pancreatic cysts and their malignant potential.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cyst | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast enhanced harmonic endoscopic ultrasound | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- study participants
- description
- After a careful endoscopic ultrasound examination in B mode of the entire pancreas, contrast enhancement was administrated to the participants. The uptake and the wash-out of the agent were followed and then a morphological diagnose was established. EUS-fine needle aspiration of the cyst wall, septa or solid components was guided by the enhancing pattern.
- interventionNames
- Diagnostic Test: Contrast enhanced harmonic endoscopic ultrasound
Primary outcomes (2)
- measure
- Specific imaging characteristics using CH-EUS
- timeFrame
- Baseline
- description
- To identify specific imaging characteristics using CH-EUS ( the contrast uptake pattern) in order to increase the diagnostic accuracy for the different type of the pancreatic cysts
- measure
- Differentiation between murale nodules and mucus clots or debris
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * presence of an undetermined pancreatic cyst \>10mm (Computer tomography, Magnetic resonance imaging); * written informed consent. Exclusion Criteria: * platelet count under 50.000 platelets per microliter (mcL) * patients with cardiorespiratory instability * refuse of the patient to participate.
References
Publications (6)
- BACKGROUNDElta GH, Enestvedt BK, Sauer BG, Lennon AM. ACG Clinical Guideline: Diagnosis and Management of Pancreatic Cysts. Am J Gastroenterol. 2018 Apr;113(4):464-479. doi: 10.1038/ajg.2018.14. Epub 2018 Feb 27. PMID 29485131
- BACKGROUNDFusaroli P, Serrani M, De Giorgio R, D'Ercole MC, Ceroni L, Lisotti A, Caletti G. Contrast Harmonic-Endoscopic Ultrasound Is Useful to Identify Neoplastic Features of Pancreatic Cysts (With Videos). Pancreas. 2016 Feb;45(2):265-8. doi: 10.1097/MPA.0000000000000441. PMID 26474428
- BACKGROUNDEuropean Study Group on Cystic Tumours of the Pancreas. European evidence-based guidelines on pancreatic cystic neoplasms. Gut. 2018 May;67(5):789-804. doi: 10.1136/gutjnl-2018-316027. Epub 2018 Mar 24. PMID 29574408
- BACKGROUNDvan Huijgevoort NCM, Del Chiaro M, Wolfgang CL, van Hooft JE, Besselink MG. Diagnosis and management of pancreatic cystic neoplasms: current evidence and guidelines. Nat Rev Gastroenterol Hepatol. 2019 Nov;16(11):676-689. doi: 10.1038/s41575-019-0195-x. Epub 2019 Sep 16. PMID 31527862
- BACKGROUNDKamata K, Kitano M. Endoscopic diagnosis of cystic lesions of the pancreas. Dig Endosc. 2019 Jan;31(1):5-15. doi: 10.1111/den.13257. Epub 2018 Sep 30. PMID 30085364
- BACKGROUNDSeicean A, Mosteanu O, Seicean R. Maximizing the endosonography: The role of contrast harmonics, elastography and confocal endomicroscopy. World J Gastroenterol. 2017 Jan 7;23(1):25-41. doi: 10.3748/wjg.v23.i1.25. PMID 28104978