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Reply to Krishna and JainSupported by: Boston Scientific Corporation http://dx.doi.org/10.13039/100008497
We thank Drs. Jain and Krishna for their interest in our recently published study on endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) of pancreatic cystic lesion using three different needle aspiration devices . We also take great interest in quantifying FNA-related adverse events in pancreatic cysts, with acute pancreatitis being the main one. We agree with the reported increased incidence of acute pancreatitis with interventional techniques, such as needle-based confocal endomicroscopy and through-the-needle microbiopsy, both of which utilize 19 G needles for access. Our study was designed to assess the baseline risk of acute pancreatitis following traditional cyst fluid aspiration for diagnostic purposes and did not include any interventions that required the introduction of another device through a 19 G needle.
In our recently published study, procedure- and needle-related serious adverse events were reported in three patients (1 % [95 % confidence interval 0.2 %–4 %]): acute pancreatitis in two patients (1 procedure-related, 1 needle-related) and aspiration pneumonia and gastroenteritis in one patient (procedure-related). In one of the two patients with acute pancreatitis, a 19 G Flex needle was used (adverse event related to the procedure); in the other, a 22 G needle was used (adverse event related to the needle).
To be more specific, cases of acute pancreatitis classified by needle size were 0.54 % (1/185) in the combined 19 G standard + 19 G Flex group; 1.54 % (1/65) in the 22G group. There is no evidence of a statistical difference between the two groups (Fisher’s exact test, P = 0.45) in terms of the occurrence of acute pancreatitis when grouped by needle size (19 G vs. 22 G). However, we would like to emphasize that the number of cases with acute pancreatitis is too small to be able to make inferences about the risk associated with the needle size, which stands as a testimony to the overall safety of EUS-FNA. We agree that the additional risk that comes with add-on interventions done through a 19 G needle is likely related to the inserted devices and the duration of intervention, rather than the mere accessing of the cyst with a 19 G needle.
26 August 2021 (online)
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- 1 Al-Haddad M, Wallace MB, Brugge W. et al. Fine-needle aspiration of pancreatic cystic lesions: a randomized study comparing standard and flexible needles with long-term follow-up. Endoscopy 2020; DOI: 10.1055/a-1311-9927.