Abstract

A previous feasibility study has suggested that needle knife fistulotomy (NFK) as an initial method for biliary access in patients with stones is associated with high levels of success and low rate of complications. This study evaluated the outcomes of NKF as an initial method for biliary access, in a large number of patients with any type of biliary pathology (tumors and stones), on the basis of success rate, complications and factors associated with success and complications. This was a prospective multicenter study of all consecutive patients who were submitted to NKF attempt as an initial method of biliary cannulation between August 2017 and November 2019 . We evaluated the success rate and complications of NKF based on the following parameters: morphology of the major papilla, biliary pathology, diameter of the terminal CBD (t-CBD) measured 1 cm from the papilla using fluoroscopic images while the patient was in a prone or supine. Papilla were classified using a previously validated international classification of the major papilla: flat type, prominent tubular non-pleated, prominent tubular pleated, prominent bulging, intradiverticular, diverticular border, unclassified papilla. Outcomes were evaluated a probit binary response regression models. We included 111 patients submitted to primary NKF, median age 70 years (17-97), 59 women (53,15%). In first ERCP, biliary cannulation rate=97.29% (108/111). The post-ERCP complications was 4,50% (n= 5), with pancreatitis rate of 3,60% (n=4) and no severe complications. Mean time to achieve cannulation was 6,25 min (sd 3,37) and mean ERCP duration=18,16 min (sd 5,58). In the regression model, complications were not explained by the papilla morphology, CBD diameter, biliary pathology (Overall F-Test=0,70;p=0,6725). When feasible NFK as initial method is associated with short time for gaining biliary access, high rate of success and low risk of complications, namely pancreatitis. The success of NFK is not related with the morphology of the papilla, t-CBD diameter, or underlying biliary pathology.

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