EUS-guided core biopsies of pancreatic solid masses using a new fork-tip needle: A multicenter prospective study.
Adenocarcinoma
/ diagnostic imaging
Adult
Aged
Aged, 80 and over
Biopsy, Large-Core Needle
/ instrumentation
Carcinoma, Neuroendocrine
/ diagnostic imaging
Endoscopic Ultrasound-Guided Fine Needle Aspiration
/ methods
Female
Humans
Male
Middle Aged
Pancreatic Neoplasms
/ diagnostic imaging
Prospective Studies
FNA
FNB
Pancreatic adenocarcinoma
SharkCore needle
Tissue acquisition
Journal
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
ISSN: 1878-3562
Titre abrégé: Dig Liver Dis
Pays: Netherlands
ID NLM: 100958385
Informations de publication
Date de publication:
09 2019
09 2019
Historique:
received:
19
11
2018
revised:
26
02
2019
accepted:
24
03
2019
pubmed:
24
4
2019
medline:
9
4
2020
entrez:
24
4
2019
Statut:
ppublish
Résumé
Endoscopic ultrasound-guided sampling (EUS sampling) is a safe and effective technique. The study aim was to evaluate the presence of a histological core from pancreatic lesions using a new 25G fork-tip needle. Observational multicenter prospective and analytical study, including consecutive patients with solid pancreatic masses referred for EUS-guided sampling. At each needle pass, the endoscopist performed macroscopic on-site evaluation (MOSE). The primary outcome was the histological core procurement rates. Secondary outcomes were the evaluation of interobserver agreement between endoscopists and pathologists, adequacy of EUS samples for the diagnosis and post-procedure adverse events. 100 patients were enrolled in 3 centers. The mean size of the lesions was 28.5 mm (SD 11.7). Final diagnoses were adenocarcinoma (68%), neuroendocrine tumor (21%), inflammatory mass/benign lesions (8.0%), and pancreatic metastasis (3.0%). The pathologists described the presence of a core in 67 samples (67.0% of patients), with poor agreement with MOSE (kappa, 0. 12; 95% CI: 0.03-0.28). The diagnostic accuracy was 93%. We observed 6% of mild adverse events. The new 25-gauge core needle showed good overall adequacy and a good rate of histological specimens during EUS sampling of solid pancreatic masses, with a minimum number of passes and no major complications. Clinicaltrial.gov number, NCT02946840.
Sections du résumé
BACKGROUND AND AIM
Endoscopic ultrasound-guided sampling (EUS sampling) is a safe and effective technique. The study aim was to evaluate the presence of a histological core from pancreatic lesions using a new 25G fork-tip needle.
METHODS
Observational multicenter prospective and analytical study, including consecutive patients with solid pancreatic masses referred for EUS-guided sampling. At each needle pass, the endoscopist performed macroscopic on-site evaluation (MOSE). The primary outcome was the histological core procurement rates. Secondary outcomes were the evaluation of interobserver agreement between endoscopists and pathologists, adequacy of EUS samples for the diagnosis and post-procedure adverse events.
RESULTS
100 patients were enrolled in 3 centers. The mean size of the lesions was 28.5 mm (SD 11.7). Final diagnoses were adenocarcinoma (68%), neuroendocrine tumor (21%), inflammatory mass/benign lesions (8.0%), and pancreatic metastasis (3.0%). The pathologists described the presence of a core in 67 samples (67.0% of patients), with poor agreement with MOSE (kappa, 0. 12; 95% CI: 0.03-0.28). The diagnostic accuracy was 93%. We observed 6% of mild adverse events.
CONCLUSION
The new 25-gauge core needle showed good overall adequacy and a good rate of histological specimens during EUS sampling of solid pancreatic masses, with a minimum number of passes and no major complications. Clinicaltrial.gov number, NCT02946840.
Identifiants
pubmed: 31010744
pii: S1590-8658(19)30531-6
doi: 10.1016/j.dld.2019.03.025
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT02946840']
Types de publication
Journal Article
Multicenter Study
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
1275-1280Informations de copyright
Copyright © 2019 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.