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Clinical Trials/NCT04389892
NCT04389892
Completed
N/A

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.

Iuliu Hatieganu University of Medicine and Pharmacy1 site in 1 country58 target enrollmentApril 1, 2018
ConditionsPancreatic Cyst

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pancreatic Cyst
Sponsor
Iuliu Hatieganu University of Medicine and Pharmacy
Enrollment
58
Locations
1
Primary Endpoint
Specific imaging characteristics using CH-EUS
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2018
End Date
May 1, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Iuliu Hatieganu University of Medicine and Pharmacy
Responsible Party
Principal Investigator
Principal Investigator

Olar Miruna-Patricia

Principal Investigator

Iuliu Hatieganu University of Medicine and Pharmacy

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.

Outcomes

Primary Outcomes

Specific imaging characteristics using CH-EUS

Time Frame: Baseline

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

Differentiation between murale nodules and mucus clots or debris

Time Frame: Baseline

The role of CH-EUS for the identification of true mural nodules

Secondary Outcomes

  • Guiding EUS-FNA by the enhancement pattern(One month)

Study Sites (1)

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