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A randomized noninferiority trial comparing the diagnostic yield of the 25G ProCore needle to the standard 25G needle in suspicious pancreatic lesions
Galab M Hassan1, Jonathan M Wyse2, Sarto C Paquin3, Gilles Gariepy4, Roula Albadine4, Benoît Mâsse5, Helen Trottier5, Anand V Sahai3
1 Division of Gastroenterology, Department of Medicine, Réseau Hospitalier Neuchâtelois, Switzerland; Department of social and preventive Medicine, School of Public Health, Université de Montréal, Québec, Canada
2 Division of Gastroenterology, Jewish General Hospital, McGill University, Montreal, Canada
3 Division of Gastroenterology, Centre Hospitalier Universitaire de Montréal, Québec, Canada
4 Department of pathology, Centre Hospitalier Universitaire de Montréal, Québec, Canada
5 Department of social and preventive Medicine, School of Public Health, Université de Montréal, Québec, Canada; Research Center, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Québec, Canada
Correspondence Address:
Galab M Hassan,
Division of Gastroenterology, Department of Medicine, Réseau Hospitalier Neuchâtelois, Switzerland
 Source of Support: None, Conflict of Interest: None DOI: 10.4103/eus.eus_69_20 PMID: 33402551
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Background and Objectives: The aim of the study was to perform the first randomized trial comparing the diagnostic yield, bloodiness, and cellularity of the 25G standard needle (25S) and the 25G ProCore™ needle (25P). Materials and Methods: All patients referred to the tertiary care referral center for EUS guided fine-needle aspiration (EUS-FNA) of suspicious solid pancreatic lesions were eligible. EUS-FNA was performed in each lesion with both 25S and 25P needles (the choice of the first needle was randomized), using a multipass sampling pattern, without stylet or suction. Rapid on-site evaluation was used when possible. Pap-stained slides were read by a single experienced cytopathologist, blinded to the needle type. Results: One hundred and forty-three patients were recruited. Samples were positive for cancer in 122/143 (85.3%) with the 25S needle versus 126/143 (88.1%) with the 25P needle, negative in 17/143 (11.9%) with the 25S needle versus 13/143 (9.1%) with the 25P needle, and suspicious in 4/143 (2.8%) with each needle. There was no difference in any outcome based on the type of the first needle. No carryover effect was detected (P = 0.214; NS). Cumulative logistic regression analyses showed no associations between the type of needle and diagnostic yield for cancer, cellularity, or bloodiness. The difference in the yield for cancer was 2.9% (−4.2; 10.1%); with the confidence interval upper within the predetermined noninferiority margin of 15%. Conclusion: The 25S needle is noninferior to the 25P needle for diagnosing cancer in suspicious pancreatic lesions.
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