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Biopsies of pancreatic lesions for better diagnostic evaluation.

22G fine aspiration needle vs 22G fine biopsy needle in the diagnostic rate of solid pancreatic lesions with suspected malignancy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6gmwrdh
Enrollment
Unknown
Registered
2020-11-26
Start date
2021-01-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid pancreatic lesions

Interventions

A total of 30 patients will be submitted to an endoscopic ultrasound with a sectorial device, performed by an experienced physician (bigger than 100 exams per year), and then the lesion will be identi

Sponsors

Faculdade de medicina da universidade de são paulo
Lead Sponsor

Eligibility

Age
18 Years to 70 Years

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

MeasureTime 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

MeasureTime 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

Public ContactEduardo Hourneaux de Moura

Faculdade de medicina da universidade de são paulo

eduardoghdemoura@gmail.com+551126616467

Outcome results

None listed

Source: REBEC (via WHO ICTRP)