Paduani GF, Felipe LM, De Paulo GA, Lenz L, Martins BC, Matuguma SE, Safatle-Ribeiro AV, De Mello ES, Maluf-Filho F. Prospective randomized study comparing Franseen 22-gauge vs standard 22-gauge needle for endoscopic ultrasound guided sampling of pancreatic solid lesions. World J Gastrointest Endosc 2025; 17(4): 101998 [DOI: 10.4253/wjge.v17.i4.101998]
Corresponding Author of This Article
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
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Randomized Clinical Trial
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (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: http://creativecommons.org/licenses/by-nc/4.0/
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
Abstract
BACKGROUND
This is a randomized study to compare the diagnostic accuracy of endoscopic ultrasound (EUS)-guided sampling of pancreatic solid lesions obtained with the 22-gauge Franseen (EUS-fine needle biopsy) vs the 22-gauge standard needle (EUS-fine needle aspiration) without rapid onsite evaluation (ROSE), since, in most endoscopy units around the world ROSE is not routinely available.
AIM
To investigate the accuracy of EUS-guided sampling of pancreatic solid lesions obtained between two different needles without ROSE.
METHODS
Patients with a solid pancreatic were included. Patients were biopsied in a randomized order. The primary endpoint was the diagnostic sensitivity for pancreatic malignancy (PM). Secondary outcomes were adequacy of the sample, the mean tissue area, the mean tumor area, and the adverse event rate.
RESULTS
The final diagnosis was pancreatic adenocarcinoma in 38 (76%), neuroendocrine tumor in 4 (8%), chronic pancreatitis in 3 (6%) patients. The sensitivity for PM with Franseen needle was 0.91 [95% confidence interval (CI): 0.80-0.98], vs 0.8 (95%CI: 0.67-0.91) (P = 0.025) with standard needle. The specificity for PM did not differentiate. The accuracy of the standard needle for PM was 0.80 (95%CI: 0.66-0.90), and the Franseen group was 0.90 (95%CI: 0.78-0.97) (P = 0.074). The technical success rates for the standard and Franseen needle groups were 94% (95%CI: 0.83-0.99) and 100% (95%CI: 0.92-1.00), respectively. The mean total tissue area in mm2 (SD) was greater in the Franseen group, 2.07 (0.22) vs 1.16 (0.17) (P < 0.01). The mean tumor area in mm2 (SD) was not different in Franseen group vs standard group, 0.42 (0.09) vs 0.47 (0.09) (P = 0.80). There were no adverse events.
CONCLUSION
The sensitivity for PM and mean total tissue area, was greater in the as compared with standard needle. The mean tumor area did not differ between the groups.
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.
