19 G nitinol needle versus 22 G needle for transduodenal endoscopic ultrasound-guided sampling of pancreatic solid masses: a randomized study.
Endoscopy
; 51(5): 436-443, 2019 05.
Article
em En
| MEDLINE
| ID: mdl-30453379
ABSTRACT
BACKGROUND:
The aim of this prospective multicenter study was to compare a flexible 19 G needle with nitinol shaft (19 G Flex) with a standard 22 G needle for transduodenal endoscopic ultrasound (EUS)-guided sampling of pancreatic head tumors.METHODS:
Patients with pancreatic head tumors requiring tissue diagnosis were randomized into two arms puncture with either a 19 G Flex needle or a 22 G needle. The primary end point was diagnostic accuracy for malignancy. The secondary end points were ergonomic scores, sample cytohistological quality, and complications. A 6-month follow-up was performed.RESULTS:
125 patients were randomized and 122 were analyzed 59 patients in the 19 G Flex arm and 63 patients in the 22 G arm. The final diagnosis was malignancy in 111 patients and benign condition in 11. In intention-to-treat analysis, the diagnostic accuracy for malignancy of the 19 G Flex and 22 G needles was 69.5â% (95â% confidence interval [CI] 56.1â%â-â80.8â%) vs. 87.3â% (95â%CI 76.5â%â-â94.4â%), respectively (Pâ=â0.02). In per-protocol analysis excluding eight technical failures in the 19 G Flex group, the diagnostic accuracy of the 19 G Flex and 22 G needles was not statistically different 80.4â% (95â%CI 66.9â%â-â90.2â%) vs. 87.3â% (95â%CI 76.5â%â-â94.4â%; Pâ=â0.12). Technical success was higher in the 22 G arm than in the 19 G Flex arm 100â% (95â%CI 94.3â%â-â100â%) vs. 86.4â% (95â%CI 75.0â%â-â94.0â%), respectively (Pâ=â0.003). Transduodenal EUS-guided sampling was more difficult with the 19 G Flex (odds ratio 0.68, 95â%CI 0.47â-â0.97).CONCLUSION:
The 19 G Flex needle was inferior to a standard 22 G needle in diagnosing pancreatic head cancer and more difficult to use in the transduodenal approach.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Pâncreas
/
Neoplasias Pancreáticas
/
Manejo de Espécimes
/
Aspiração por Agulha Fina Guiada por Ultrassom Endoscópico
/
Agulhas
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
/
Guideline
Limite:
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article