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
ARTICLE HIGHLIGHTS
Research background

Endoscopic ultrasound-guided tissue acquisition (EUS-TA) is an established modality for the evaluation of pancreatic lesions. Recently fine needle biopsy (FNB) has been introduced in order to obtain samples with preserved tissue architecture. Studies evaluating one of the most recent introduced FNB needles, the Franseen needle, have shown very promising results of high histological tissue acquisition rate.

Research motivation

So far there is little evidence about the performance of the Franseen needle in the evaluation of pancreatic lesions, when applying a standardised protocol of a predetermined low number of needle passes, without access to an on-site cytopathologist and flushing out the obtained material direct into formalin.

Research objectives

We performed a prospective, single-arm study to evaluate the clinical performance of the 22-gauge (22G) Franseen needle, when sampling pancreatic lesions according to a standardised protocol, focusing on the quality of the acquired histological specimens.

Research methods

Consecutive patients with an indication for EUS-FNB for the assessment of pancreatic lesions from June 2017 to December 2018 underwent a puncture of the lesion two times using the 22G Franseen needle in our department. The obtained material was treated like a biopsy specimen, placed directly into formalin, completely embedded in paraffin and cut to provide heamatoxylin-eosin stained sections for histological analysis. Our primary endpoint was the acquisition rate of high-quality histological specimen, regarded by the pathologist as representative (Payne score 3). Secondary endpoints were size of the core specimen, the diagnostic accuracy and the complication rate. The gold standard for definite diagnosis was considered one or more of the following: A definite histology obtained from EUS-FNB, a surgical resection or clinical follow-up up to twelve months.

Research results

Forty patients with a mean age of 67.2 years were included in this study. Tissue acquisition was achieved in all cases, whereas high-quality histology, rated with Payne score 3, was obtained in 37 out of 40 cases (92.5%). A correct diagnosis (diagnostic accuracy) was made in 34 out of 40 cases (85%). The final diagnosis was confirmed based on definite EUS-FNB histology in 21 patients, on surgical resection in 8 patients, on both definite EUS-FNB and surgery in 5 further patients and on interval follow-up in 6 patients. The only complication occurred was a self-limiting bleeding in the puncture site.

Research conclusions

We demonstrated that EUS-FNB of pancreatic lesions with the 22G Franseen needle following a standardised simplified protocol achieved a high acquisition rate of representative histological specimen and a high diagnostic accuracy.

Research perspectives

We consider that further prospective studies with a standardised protocol of a predetermined low number of needle passes are required to draw a conclusion about the need of ROSE.