Randomized Clinical Trial
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Oct 21, 2016; 22(39): 8820-8830
Published online Oct 21, 2016. doi: 10.3748/wjg.v22.i39.8820
22-gauge core vs 22-gauge aspiration needle for endoscopic ultrasound-guided sampling of abdominal masses
William Sterlacci, Athanasios D Sioulas, Lothar Veits, Pervin Gönüllü, Guido Schachschal, Stefan Groth, Mario Anders, Christos K Kontos, Theodoros Topalidis, Andrea Hinsch, Michael Vieth, Thomas Rösch, Ulrike W Denzer
William Sterlacci, Lothar Veits, Michael Vieth, Institute of Pathology, Clinic of Bayreuth, 95445 Bayreuth, Germany
Athanasios D Sioulas, Pervin Gönüllü, Guido Schachschal, Stefan Groth, Mario Anders, Thomas Rösch, Ulrike W Denzer, Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, 20246 Hamburg, Germany
Christos K Kontos, Department of Biochemistry and Molecular Biology, University of Athens, 15701 Athens, Greece
Theodoros Topalidis, Institute of Pathology, 30539 Hannover, Germany
Andrea Hinsch, Institute of Pathology, University Hospital Hamburg-Eppendorf, 20246 Hamburg, Germany
Author contributions: Denzer UW conceived the idea and designed the study, performed the endoscopies, collected the data, reviewed the draft, and approved the final manuscript; Sioulas AD performed the literature search and drafted and approved the final manuscript; Sterlacci W, Veits L, Topalidis T, Hinsch A and Vieth M performed the cytohistological analyses of the specimens, reviewed the draft, and approved the final manuscript; Kontos CK analyzed the data, reviewed the draft, and approved the final manuscript; Schachschal G, Groth S and Anders M performed the endoscopies, reviewed the draft, and approved the final manuscript; Rösch 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 Institutional Clinical Research Ethics Committee of the University Hospital Hamburg-Eppendorf (study number: PV 3835).
Clinical trial registration statement: The study has been registered at Clinicaltrials.gov (ID: NCT02181140).
Informed consent statement: All of the individuals who participated in the study provided their written informed consent prior to study enrollment.
Conflict-of-interest statement: None to declare.
Data sharing statement: No additional data are available.
Open-Access: 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/
Correspondence to: Athanasios D Sioulas, MD, PhD, Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany. athsioulas@yahoo.gr
Telephone: +49-0-407410 Fax: +49-0-407410-44420
Received: June 25, 2016
Peer-review started: June 27, 2016
First decision: August 8, 2016
Revised: August 21, 2016
Accepted: September 14, 2016
Article in press: September 14, 2016
Published online: October 21, 2016
Processing time: 117 Days and 16.1 Hours
Abstract
AIM

To compare the aspiration needle (AN) and core biopsy needle (PC) in endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of abdominal masses.

METHODS

Consecutive patients referred for EUS-FNA were included in this prospective single-center trial. Each patient underwent a puncture of the lesion with both standard 22-gauge (G) AN (Echo Tip Ultra; Cook Medical, Bloomington, Indiana, United States) and the novel 22G PC (EchoTip ProCore; Cook Medical, Bloomington, Indiana, United States) in a randomized fashion; histology was attempted in the PC group only. The main study endpoint was the overall diagnostic accuracy, including the contribution of histology to the final diagnosis. Secondary outcome measures included material adequacy, number of needle passes, and complications.

RESULTS

Fifty six consecutive patients (29 men; mean age 68 years) with pancreatic lesions (n = 38), lymphadenopathy (n = 13), submucosal tumors (n = 4), or others lesions (n = 1) underwent EUS-FNA using both of the needles in a randomized order. AN and PC reached similar overall results for diagnostic accuracy (AN: 88.9 vs PC: 96.1, P = 0.25), specimen adequacy (AN: 96.4% vs PC: 91.1%, P = 0.38), mean number of passes (AN: 1.5 vs PC: 1.7, P = 0.14), mean cellularity score (AN: 1.7 vs PC: 1.1, P = 0.058), and complications (none). A diagnosis on the basis of histology was achieved in the PC group in 36 (64.3%) patients, and in 2 of those as the sole modality. In patients with available histology the mean cellularity score was higher for AN (AN: 1.7 vs PC: 1.0, P = 0.034); no other differences were of statistical significance.

CONCLUSION

Both needles achieved high overall diagnostic yields and similar performance characteristics for cytological diagnosis; histological analysis was only possible in 2/3 of cases with the new needle.

Keywords: Endoscopic ultrasound; Cytology; Fine needle aspiration; Abdominal tumors; Core biopsy needle

Core tip: Endoscopic ultrasound-guided fine needle aspiration and cytological analysis of the obtained material represents an established modality for diagnosis of intra- and paramural lesions. Recently developed fenestrated needles enable specimen acquisition for histological analysis aiming to improve diagnostic accuracy. We prospectively compared the 22 gauge standard aspiration needle with the same-diameter novel core biopsy needle in sampling of abdominal masses. Both needles yielded similar overall diagnostic accuracy, while no significant differences were evident regarding sample adequacy for the analysis, quality, and cellularity of specimens, number of needle passes, feasibility, and complications. The diagnostic contribution of histology with the novel needle was limited.