Randomized Clinical Trial
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Endosc. Apr 16, 2025; 17(4): 101998
Published online Apr 16, 2025. doi: 10.4253/wjge.v17.i4.101998
Prospective randomized study comparing Franseen 22-gauge vs standard 22-gauge needle for endoscopic ultrasound guided sampling of pancreatic solid lesions
Gabriela F Paduani, Leika M Felipe, Gustavo A De Paulo, Luciano Lenz, Bruno C Martins, Sergio E Matuguma, Adriana V Safatle-Ribeiro, Evandro S De Mello, Fauze Maluf-Filho
Gabriela F Paduani, Gustavo A De Paulo, Luciano Lenz, Bruno C Martins, Sergio E Matuguma, Adriana V Safatle-Ribeiro, Fauze Maluf-Filho, Department of Gastroenterology, Instituto do Cancer do Estado de Sao Paulo, Sao Paulo 01246-000, Brazil
Leika M Felipe, Evandro S De Mello, Department of Pathology, Instituto do Cancer, Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo 01246-000, Brazil
Author contributions: Maluf-Filho F, Martins BC, De Paulo GA, Felipe LM, Lenz L, Matuguma SE, Safatle-Ribeiro AV, De Mello ES, Paduani GF contributed to planning/designing, conduct, interpretation, and writing of this research.
Institutional review board statement: The study was reviewed and approved by the Institutional Review Board, (Approval No. 26962419.3.0000.0065).
Clinical trial registration statement: This study is registered at the Instituto do Cancer do Estado de Sao Paulo between December 2019 and January 2023 (Registration number at clinicaltrials.gov: NCT04877340).
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: The authors declare that they have no conflict of interest.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at gabrielapaduani@usp.br. The consent was not obtained but the presented data are anonymized and risk of identification is low.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Gabriela F Paduani, MD, Doctor, Department of Gastroenterology, Instituto do Cancer do Estado de Sao Paulo, Av Dr Arnaldo, 251, Sao Paulo 01246-000, Brazil. gabrielapaduani@usp.br
Received: October 8, 2024
Revised: January 21, 2025
Accepted: March 13, 2025
Published online: April 16, 2025
Processing time: 191 Days and 18.2 Hours
Core Tip

Core Tip: The main of the study was based in assess the sensitivity of endoscopic ultrasound needles for diagnosing pancreatic malignancy. We found that the diagnostic sensitivity for pancreatic malignancy as well as the mean total tissue area collected was greater with the Franseen needle group compared with the standard needle group. Taking into account, the procedure was done in the absence of an onsite site pathologist for evaluation of the sample collected, bringing important contribution to institutions that do not have pathologist in the examination room.