The Added Value of Contrast Enhancement for Guiding EUS-FNA in Solid Pancreatic Masses

Study Overview
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Brief Summary
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A prospective study designed to show the superiority of contrast guided echoendoscopy versus conventional echoendoscopy

Detailed Description
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A prospective study that compares the results using FNA contrast echoendoscopy versus standard FNA echoendoscopy in the diagnosis of solid pancreatic tumors

Official Title
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The Added Value of Contrast Enhancement for Guiding EUS-FNA in Solid Pancreatic Masses

Conditions
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Endoscopic Ultrasonography

Intervention / Treatment
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* Diagnostic Test: Endosonography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: solid pancreatic tumor lesions Exclusion Criteria: severe coagulopathy of trombocytopenia <50.000 patients refuse for biopsy prelevation or pacient's refuse to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 86 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: contrast enhanced FNA endosonography<br>First passage in the solid pancreatic tumor using FNA endosonography then with the contrast enhanced FNA endosonography | Diagnostic Test: Endosonography<br>* Puncture of the pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control. Passage in the same pancreatic mass of first using standard FNA method then contrast enhanced FNA method or vice versa according to the randomization<br>|
| Active Comparator: FNA standard endosonography<br>First passage in the solid pancreatic tumor using contrast enhanced FNA endosonography then with the FNA endosonography | Diagnostic Test: Endosonography<br>* Puncture of the pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control. Passage in the same pancreatic mass of first using standard FNA method then contrast enhanced FNA method or vice versa according to the randomization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of CEUS FNA endosonography versus standard FNA endosonography in the etiological cyto histological of pancreatic solid tumors using histology core as comparison between the two methods | Diagnostic accuracy of CEUS FNA endosonography versus standard FNA endosonography in the etiological cyto histological of pancreatic solid tumors using histology core as comparison between the two methods | an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of histological specimen(histology core) obtained with the two types of FNA biopsies (contrast enhanced and standard) | Visual analogic scale | 5 days | 
| Dysfunction in the two types of biopsies | failure or difficulty reports with each procedure (%) | day one | 
| Comparison between standand endosonography and contrast enhanced endosonography in obtaining a superior quality in obtaining histology core | Visual analogic scale | day one | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contrast endosonograpy