Clinical Trials Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Oct 7, 2020; 26(37): 5693-5704
Published online Oct 7, 2020. doi: 10.3748/wjg.v26.i37.5693
Endoscopic ultrasound-fine needle biopsies of pancreatic lesions: Prospective study of histology quality using Franseen needle
Petros Stathopoulos, Anika Pehl, Lutz Philipp Breitling, Christian Bauer, Tobias Grote, Thomas Mathias Gress, Carsten Denkert, Ulrike Walburga Denzer
Petros Stathopoulos, Lutz Philipp Breitling, Christian Bauer, Tobias Grote, Thomas Mathias Gress, Ulrike Walburga Denzer, Division of Endoscopy, Department of Gastroenterology, Endocrinology, Metabolism and Clinical Infectiology, University Hospital Marburg, Marburg 35043, Hessen, Germany
Anika Pehl, Carsten Denkert, Institute of pathology, University Hospital Marburg, Marburg 35043, Hessen, Germany
Author contributions: Denzer UW conceived the idea and designed the study, performed the endoscopies, reviewed the draft and approved the final manuscript; Stathopoulos P performed the literature search, collected the data and drafted and approved the final manuscript; Pehl A and Denkert C performed the histological analyses of the specimens, reviewed the draft and approved the final manuscript; Breitling LP (MSc in Epidemiology) analysed the data reviewed the draft and approved the final manuscript; Bauer C and Grote T performed the endoscopies, reviewed the draft and approved the final manuscript; Gress T critically reviewed the draft and approved the final manuscript; all the authors contributed to this manuscript.
Institutional review board statement: This study was reviewed and approved by the local ethical review board (Philipps-Universität Marburg, study number 174/16).
Clinical trial registration statement: This study has been registered at https://clinicaltrials.gov/ct2/show/NCT03621852 (ID: NCT03621852).
Informed consent statement: All the individuals who participated in this study provided their written informed consent prior to study enrolment.
Conflict-of-interest statement: Division of Endoscopy took grant from Boston Scientific Medizintechnik GmbH, outside the submitted work.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
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: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Ulrike Walburga Denzer, MD, Professor, Division of Endoscopy, Department of Gastroenterology, Endocrinology, Metabolism and Clinical Infectiology, University Hospital Marburg, Baldingerstrasse 1, Marburg 35043, Hessen, Germany. uwdenzer@gmail.com
Received: July 29, 2020
Peer-review started: July 29, 2020
First decision: August 8, 2020
Revised: August 21, 2020
Accepted: September 15, 2020
Article in press: September 15, 2020
Published online: October 7, 2020
Processing time: 60 Days and 14 Hours
Abstract
BACKGROUND

The introduction of fine needle biopsies (FNB) to clinical practice presents a changing trend towards histology in the endoscopic ultrasound-guided tissue acquisition (EUS-TA).

AIM

To evaluate the clinical performance of a new FNB needle, the 22-gauge (22G) Franseen needle, when sampling pancreatic solid lesions.

METHODS

Consecutive patients with an indication for EUS-TA for the assessment of pancreatic solid lesions were included in this prospective, single-center, single-arm trial. Each patient underwent a puncture of the lesion two times using the 22G Franseen needle and the obtained samples were directly placed into formalin for histological analysis. The primary study endpoint was the rate of high-quality obtained specimen. Secondary endpoints included the length and diameter of the core specimen, the diagnostic accuracy and the complication rate.

RESULTS

From June 2017 to December 2018, forty patients with pancreatic solid lesions (22 females; mean age 67.2 years) were enrolled. Tissue acquisition was achieved in all cases. High-quality histology, rated with Payne score 3, was obtained in 37/40 cases (92.5%) after two needle passes. The mean size of the acquired histological core tissue was 1.54 mm × 0.39 mm. The diagnostic accuracy for the correct diagnosis was 85% (34/40). Only one adverse event was occurred, consisting of a self-limiting bleeding in the puncture site.

CONCLUSION

The 22G Franseen needle achieved according to our standardized protocol a high rate of histological core procurement, and a high diagnostic accuracy, with one minor adverse event reported.

Keywords: Endosonography; Fine needle biopsy; Histology; Pancreatic lesions; Franseen needle

Core Tip: Endoscopic ultrasound-guided tissue acquisition (EUS-TA) has been established in the evaluation of pancreatic masses and recently developed fine needle biopsy (FNB) needles improve the diagnostic yield of EUS-TA providing tissue blocks for performing immunohistochemistry and flow cytometry. We prospectively evaluated the Franseen needle when sampling pancreatic solid lesions. EUS-FNB with the 22-gauge Franseen needle achieved a high rate of histological core procurement and high diagnostic accuracy after only two passes and flushing out the acquired samples directly into formalin, without a rapid on-site evaluation by a cytopathologist or macroscopic on-site evaluation by the endoscopist.