Solid pancreatic lesions
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with solid pancreatic lesion diagnosed through imaging method who attended the Endoscopy Department of Hospital das Clínicas of the School of Medicine of University of São Paulo (HC-FMUSP), Digestive endoscopy unit of Fortaleza General Hospital, or in the Digestive endoscopy unit of Hospital das Clínicas of Ribeirão Preto. Age between 18 and 70 years; Signed the Informed Consent Form (ICF)
Exclusion criteria
Exclusion criteria: No lesion identified through EUS; Duodenal papilla tumor; Unavailability of needles at the hospital at the time of the procedure; Presence of large vein or biliary stent in the puncture path; Contraindication for endoscopic puncture of the lesion; Current use of anticoagulants or known change in coagulation; Suspended or incomplete procedures; Participation in another clinical protocol that may affect the patient safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the impact on the diagnostic value using the FNB needle punch in relation to the FNA, using the method of analysis of accuracy, sensitivity, specificity, positive and negative predictive value, observing if there is an increase or not in percentage of these analyzes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the complication rates of each technique used in percentage when comparing the two puncture techniques used ;Evaluate the diagnostic performance of each needle for the analysis of accuracy, sensitivity, specificity, positive predictive value, negative predictive value;Evaluate the diagnostic performance of each pathologist regarding the analysis of accuracy, sensitivity, specificity, positive predictive value, negative predictive value | — |
Countries
Brazil
Contacts
Faculdade de medicina da universidade de são paulo