NCT04164017

Impact of Suction in the EUS-guided Fine Needle Biopsy of Solid Pancreatic Lesions

Comparative Evaluation of the Diagnostic Yield and Sample Quality in Endoscopic Ultrasound(EUS)-Guided Fine Needle Biopsy(FNB) of Pancreatic Solid Lesions With and Without Syringe Suction

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Centro Hospitalar De São João, E.P.E. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Tissue acquisition by Endoscopic Ultrasound (EUS) has become a modality of diagnosis and clinical orientation for several diseases. Although tissue acquisition traditionally involves the cytological diagnosis (using fine-needle aspiration/FNA), the importance of obtaining a core for histological examination (by fine-needle biopsy/FNB) has recently been recognized. Currently, there is no clear establishment of the usefulness of syringe suction for the diagnostic accuracy of solid pancreatic lesions when FNB is used. Because of that, the investigators aimed to compare sensitivity, sample adequacy, and diagnostic yield of solid pancreatic lesions EUS-guided sampling using with and without syringe suction. The study will be conducted on a consecutive sample of patients proposed to perform EUS for solid pancreatic lesions characterization, in which the clinical and imaging findings justify the need for an FNB. For each case, FNB will be performed using two punctures: one with 20mL syringe suction, and another without suction. The order in which they will be performed will be known only by the performing physician and the nursing team at the time that FNB is proposed. This information will be concealed from the pathologist responsible for sample analysis. Clinical care during and after the procedure will follow the existing guidelines. Participants will undergo a single clinical evaluation (at the time of endoscopy and recovery) without the need for follow-up visits.

Conditions

• Biopsy, Fine-Needle
• Endosonography
• Pancreatic Neoplasm

Interventions

Type	Name	Description
DEVICE	EUS-guided FNB with Syringe Suction	For each case, FNB will be performed using two punctures: one with 20mL syringe suction and another without aspiration. The order in which they will be performed will be known only by the performing physician and the nursing team at the time that FNB is proposed. This information will be concealed from the pathologist responsible for sample analysis.
DEVICE	EUS-guided FNB without Syringe Suction	For each case, FNB will be performed using two punctures: one with 20mL syringe suction and another without aspiration. The order in which they will be performed will be known only by the performing physician and the nursing team at the time that FNB is proposed. This information will be concealed from the pathologist responsible for sample analysis.

Timeline

• Start date: 2019-06-01
• Primary completion: 2020-04-01
• Completion: 2020-04-01
• First posted: 2019-11-15
• Last updated: 2019-11-15

Locations

1 site across 1 country: Portugal