Clinical trial NCT04389892: Usefulness of Contrast Enhanced Harmonic Endoscopic Ultrasound for Pancreatic Cysts
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cyst
Keywords: contrast-enhanced harmonic endoscopic ultrasound (CH-EUS)
EUS-FNA
pancreatic cyst
pancreas
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients diagnosed with unclear cystic lesions who underwent CH-EUS at our Institute
Primary purpose: DIAGNOSTIC

Brief summary: The study evaluates the role of contrast-enhanced harmonic endoscopic ultrasound (CH-EUS) for the differentiation of the pancreatic cysts and their malignant potential.

Detailed description: Due to the increase use of cross-sectional imaging techniques for varied medical conditions more and more pancreatic cysts are incidentally found. Magnetic resonance imaging revealed a prevalence of incidental pancreatic cystic neoplasm (PCN) in adults between 2,4-49,1% and autopsy studies showed that half of the individuals had pancreatic cysts.

There is a great variety of pancreatic cysts, they are mainly divided in neoplastic or non-neoplastic (i.e pseudocyst). Pseudocysts appear after acute or chronic pancreatitis and represent only 20% of all pancreatic cysts.. PCN include a diverse group of pancreatic cysts including mucin-producing (Intraductal papillary mucinous neoplasm (IPMN), mucinous cystic neoplasm (MCN)) and nonmucin-producing lesions (Serous cystadenoma (SCN), Solid pseudopapillary neoplasm(SPN) cystic neuroendocrine tumor(cNET)) with different morphology and progression to malignancy. SPN's,cNET are considered premalignant or malignant conditions and require surveillance or surgical resection. SCN instead are benign and surveillance is not necessary. Resection is considered only if symptoms are present.

The discrimination between the different cyst types is crucial for the therapeutic approach. Their morphology can be similar and sometimes it's a challenge to diagnose them.There are many tools but none is good enough to be used alone.

Contrast-enhanced harmonic endoscopic ultrasound using low mechanical index (0.12-0.4) is an additional test to assess the vascularization of the cystic wall and the septa and solid component for the differential diagnosis of PCN.

Our aim was to identify specific imaging characteristics using CH-EUS in order to increase the diagnostic accuracy for potential malignant pancreatic cysts.

Eligibility criteria: 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.

Primary outcomes:
measure: Specific imaging characteristics using CH-EUS
timeFrame: Baseline
measure: Differentiation between murale nodules and mucus clots or debris
timeFrame: Baseline
Secondary outcomes:
measure: Guiding EUS-FNA by the enhancement pattern
timeFrame: One month
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Regional Institite of Gastroenterology and hepatology
Study officials:
affiliation: Regional Institute of Gastroenterology and Hepatology Cluj-Napoca
name: Andrada Seicean, MD,PhD
role: STUDY_DIRECTOR
References:
citation: Elta 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.
citation: Fusaroli 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.
citation: European 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.
citation: van 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.
citation: Kamata 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.
citation: Seicean 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.