Abstract
Previous studies have suggested that the success and complications of precut needle knife fistulotomy (NKF) for achieving biliary access is largely dependent of the endoscopic morphology of the ampulla of Vater and also of the bile duct size. However, no study has addressed this topic. This study evaluated the outcomes of NKF on the basis of the morphology of the major papilla and of the size of the bile duct. This was a prospective multicenter study of all consecutive patients who were submitted to early NKF attempt for biliary access between August 2017 and August 2019. We evaluated the success rate and complications of NKF based on the following parameters: transverse and longitudinal measures of the papilla obtained using a visual method; diameter of the terminal CBD (t-CBD) measured 1 cm from the papilla using fluoroscopic images. Papilla were classified using a previously validated international classification of the major papilla into 7 categories. Outcomes were evaluated by a binary response regression models. We included 275 patients submitted to NKF, median age 75 years (17-97), 158 women(57.45%). NKF were performed in: 46 flat type papillas(16,67%), 102 prominent tubular non-pleated (37,21%), 74 prominent tubular pleated(26,74%), 27 prominent bulging(9,69%), 3 intradiverticular(1,09%) , 10 diverticular border(3,64%), 13 unclassified(4,65%). The cannulation rate was 97,07%. The post-ERCP complications rate were 9,09% (n= 25), with pancreatitis rate=6,18% (n=17) and no deaths. Cannulation success and complications were not significantly different among the seven papilla categories. In the regression model, cannulation and complications were not explained by the papilla morphology and the CBD diameter(Overall F-Test=0,46;p<0,80). The biliary cannulation and post-ERCP complications are not associated with papillary morphology or the distal size of CBD. The decision to use NKF for biliary access should not be conditioned by the papillary morphology.
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