19 G nitinol needle versus 22 G needle for transduodenal endoscopic ultrasound-guided sampling of pancreatic solid masses: a randomized study

Arthur Laquière; Christine Lefort; Frédérique Maire; Alain Aubert; Rodica Gincul; Frédéric Prat; Philippe Grandval; Olivier Croizet; James Boulant; Geoffroy Vanbiervliet; Guillaume Pénaranda; Laurence Lecomte; Bertrand Napoléon; Christian Boustière

doi:10.1055/a-0757-7714

Endoscopy, Inhaltsverzeichnis

Endoscopy 2019; 51(05): 436-443
DOI: 10.1055/a-0757-7714

Original article

19 G nitinol needle versus 22 G needle for transduodenal endoscopic ultrasound-guided sampling of pancreatic solid masses: a randomized study

Arthur Laquière

¹Hepatogastroenterology Department, Hôpital Saint Joseph, Marseille, France

,

Christine Lefort

²Hepatogastroenterology Department, Hôpital Privé Jean Mermoz, Lyon, France

,

Frédérique Maire

³Hepatogastroenterology Department, Hôpital Beaujon (CHU) AP-HP, Clichy, France

,

Alain Aubert

⁴Hepatogastroenterology Department, Clinique Du Parc St Lazare, Beauvais, France

,

Rodica Gincul

⁵Hepatogastroenterology Department, Hôpital Edouard Herriot (CHU) HCL, Lyon, France

,

Frédéric Prat

⁶Hepatogastroenterology Department, Hôpital Cochin(CHU) AP-HP, Paris, France

,

Philippe Grandval

⁷Hepatogastroenterology Department, Hôpital La Timone (CHU) AP-H, Marseille, France

,

Olivier Croizet

⁸Hepatogastroenterology Department, Clinique Pasteur, Toulouse, France

,

James Boulant

⁹Hepatogastroenterology Department, Clinique du Palais, Grasse, France

,

Geoffroy Vanbiervliet

¹⁰Hepatogastroenterology Department, Hôpital L’Archet (CHU), Nice, France

,

Guillaume Pénaranda

¹¹AlphaBio Laboratory, Biostatistics Department, Hôpital Européen, Marseille, France

,

Laurence Lecomte

¹Hepatogastroenterology Department, Hôpital Saint Joseph, Marseille, France

,

Bertrand Napoléon

²Hepatogastroenterology Department, Hôpital Privé Jean Mermoz, Lyon, France

,

Christian Boustière

¹Hepatogastroenterology Department, Hôpital Saint Joseph, Marseille, France

› Institutsangaben

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 69.5 % (95 % confidence interval [CI] 56.1 % – 80.8 %) vs. 87.3 % (95 %CI 76.5 % – 94.4 %), respectively (P = 0.02). 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: 80.4 % (95 %CI 66.9 % – 90.2 %) vs. 87.3 % (95 %CI 76.5 % – 94.4 %; P = 0.12). Technical success was higher in the 22 G arm than in the 19 G Flex arm: 100 % (95 %CI 94.3 % – 100 %) vs. 86.4 % (95 %CI 75.0 % – 94.0 %), respectively (P = 0.003). Transduodenal EUS-guided sampling was more difficult with the 19 G Flex (odds ratio 0.68, 95 %CI 0.47 – 0.97).

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.

Volltext

Referenzen

References
1 Hewitt MJ, McPhail MJW, Possamai L. et al. EUS-guided FNA for diagnosis of solid pancreatic neoplasms: a meta-analysis. Gastrointest Endosc 2012; 75: 319-331
2 Song TJ, Kim JH, Lee SS. et al. The prospective randomized, controlled trial of endoscopic ultrasound-guided fine-needle aspiration using 22G and 19G aspiration needles for solid pancreatic or peripancreatic masses. Am J Gastroenterol 2010; 105: 1739-1745
3 Itoi T, Itokawa F, Sofuni A. et al. Evaluation of 19-gauge endoscopic ultrasonography aspiration needles using various echoendoscopes. Endosc Int Open 2013; 1: 24-30
4 Polkowski M, Jenssen C, Kaye P. et al. Technical aspects of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Guideline – March 2017. Endoscopy 2017; 49: 989-1006
5 Dumonceau J-M, Deprez PH, Jenssen C. et al. Indications, results, and clinical impact of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline – Updated January 2017. Endoscopy 2017; 49: 695-714
6 Varadarajulu S, Bang JY, Hebert-Magee S. Assessment of the technical performance of the flexible 19-gauge EUS-FNA needle. Gastrointest Endosc 2012; 76: 336-343
7 Mair S, Dunbar F, Becker PJ. et al. Fine needle cytology – is aspiration suction necessary? A study of 100 masses in various sites. Acta Cytol 1989; 33: 809-813
8 Cotton PB, Eisen GM, Aabakken L. et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446-454
9 Hahn GJ, Meeker WQ. Statistical intervals: a guide for practitioners. New York: John Wiley & Sons; 2011
10 Khan MA, Grimm IS, Ali B. et al. A meta-analysis of endoscopic ultrasound-fine-needle aspiration compared to endoscopic ultrasound-fine-needle biopsy: diagnostic yield and the value of onsite cytopathological assessment. Endosc Int Open 2017; 5: E363-375
11 Kamata K, Kitano M, Yasukawa S. et al. Histologic diagnosis of pancreatic masses using 25-gauge endoscopic ultrasound needles with and without a core trap: a multicenter randomized trial. Endoscopy 2016; 48: 632-638
12 Lee YN, Moon JH, Kim HK. et al. Core biopsy needle versus standard aspiration needle for endoscopic ultrasound-guided sampling of solid pancreatic masses: a randomized parallel-group study. Endoscopy 2014; 46: 1056-1062
13 Vanbiervliet G, Napoléon B, Saint Paul MC. et al. Core needle versus standard needle for endoscopic ultrasound-guided biopsy of solid pancreatic masses: a randomized crossover study. Endoscopy 2014; 46: 1063-1070
14 Bang JY, Hawes R, Varadarajulu S. A meta-analysis comparing ProCore and standard fine-needle aspiration needles for endoscopic ultrasound-guided tissue acquisition. Endoscopy 2016; 48: 339-349
15 Lee BS, Cho C-M, Jung MK. et al. Comparison of histologic core portions acquired from a core biopsy needle and a conventional needle in solid mass lesions: a prospective randomized trial. Gut Liver 2017; 11: 559-566
16 Kandel P, Tranesh G, Nassar A. et al. EUS-guided fine needle biopsy sampling using a novel fork-tip needle: a case-control study. Gastrointest Endosc 2016; 84: 1034-1039
17 Jovani M, Abidi WM, Lee LS. Novel fork-tip needles versus standard needles for EUS-guided tissue acquisition from solid masses of the upper GI tract: a matched cohort study. Scand J Gastroenterol 2017; 52: 784-787
18 Bang JY, Hebert-Magee S, Hasan MK. et al. Endoscopic ultrasonography-guided biopsy using a Franseen needle design: initial assessment. Dig Endosc 2017; 29: 338-346
19 Abdelfatah MM, Grimm IS, Gangarosa LM. et al. Cohort study comparing the diagnostic yields of 2 different EUS fine-needle biopsy needles. Gastrointest Endosc 2018; 87: 495-500
20 Bang JY, Hebert-Magee S, Navaneethan U. et al. Randomized trial comparing the Franseen and Fork-tip needles for EUS-guided fine-needle biopsy of solid pancreatic mass lesions. Gastrointest Endosc 2018; 87: 1432-1438