Fine-needle aspiration of pancreatic cystic lesions: a randomized study with long-term follow-up comparing standard and flexible needles.
Journal
Endoscopy
ISSN: 1438-8812
Titre abrégé: Endoscopy
Pays: Germany
ID NLM: 0215166
Informations de publication
Date de publication:
11 2021
11 2021
Historique:
aheadofprint:
16
11
2020
pubmed:
17
11
2020
medline:
6
11
2021
entrez:
16
11
2020
Statut:
ppublish
Résumé
Pancreatic cystic lesions (PCLs) are increasingly found on cross-sectional imaging, with the majority having a low risk for malignancy. The added value of fine-needle aspiration (FNA) in risk stratification remains unclear. We evaluated the impact of three FNA needles on diagnostic accuracy, clinical management, and the ability to accrue fluid for tumor markers. A multicenter prospective trial randomized 250 patients with PCLs ≥ 13 mm 2:1:1 to 19G Flex, 19G, and 22G needles with crossover for repeated FNA procedures. Diagnostic accuracy was established at 2-year follow-up, with the final diagnosis from surgical histopathology or consensus diagnosis by experts based sequentially on clinical presentation, imaging, and aspirate analysis in blinded review. Enrolled patients (36 % symptomatic) had PCLs in the head (44 %), body (28 %), and tail (26 %). Percentage of cyst volume aspirated was 78 % (72 % - 84 %) for 19G Flex, 74 % (64 % - 84 %) for 22G, and 73 % (63 % - 83 %) for 19G ( Our study results demonstrate a statistically significant difference among the three needles in the overall success rate for aspiration, but not in the percentage of cyst volume aspirated. Flexible needles may be particularly valuable in sampling cystic PCLs in the pancreatic head/uncinate process.
Sections du résumé
BACKGROUND
Pancreatic cystic lesions (PCLs) are increasingly found on cross-sectional imaging, with the majority having a low risk for malignancy. The added value of fine-needle aspiration (FNA) in risk stratification remains unclear. We evaluated the impact of three FNA needles on diagnostic accuracy, clinical management, and the ability to accrue fluid for tumor markers.
METHODS
A multicenter prospective trial randomized 250 patients with PCLs ≥ 13 mm 2:1:1 to 19G Flex, 19G, and 22G needles with crossover for repeated FNA procedures. Diagnostic accuracy was established at 2-year follow-up, with the final diagnosis from surgical histopathology or consensus diagnosis by experts based sequentially on clinical presentation, imaging, and aspirate analysis in blinded review.
RESULTS
Enrolled patients (36 % symptomatic) had PCLs in the head (44 %), body (28 %), and tail (26 %). Percentage of cyst volume aspirated was 78 % (72 % - 84 %) for 19G Flex, 74 % (64 % - 84 %) for 22G, and 73 % (63 % - 83 %) for 19G (
CONCLUSIONS
Our study results demonstrate a statistically significant difference among the three needles in the overall success rate for aspiration, but not in the percentage of cyst volume aspirated. Flexible needles may be particularly valuable in sampling cystic PCLs in the pancreatic head/uncinate process.
Banques de données
ClinicalTrials.gov
['NCT01711294']
Types de publication
Clinical Trial
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1132-1140Commentaires et corrections
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Informations de copyright
Thieme. All rights reserved.
Déclaration de conflit d'intérêts
Dr. Al-Haddad has received consulting fees from Boston Scientific Corporation and Takeda Pharmaceuticals. Dr. Wallace has consulting relationships with Cosmo/Aries Pharmaceuticals, Anx Robotica, Covidien, GI Supply, Endokey, Endostart, and Microtek, holds stock with Virgo Inc., and has received research grants from Boston Scientific Corporation, Fujifilm, Olympus, Medtronic, and NinePoint Medical. Dr. Sethi has consulting relationships with Boston Scientific Corporation, Olympus, and FUJIFILM. Dr. Pleskow has consulting relationships with Boston Scientific Corporation, Medtronic, Olympus, Fujifilm, and NinePoint Medical. Dr. Pannala has consulting relationships with HCL America and has received general payments from Boston Scientific Corporation, Apollo Endosurgery, Abbvie, and Olympus America. Dr. DeWitt has consulting relationships with Boston Scientific Corporation and has received research grant support from Concordia Laboratories Inc. and Vyaire Medical, Inc. Dr. Faigel has received research support from Boston Scientific Corporation. The remaining authors declare that they have no conflict of interest.