Abstract

Needle knife fistulotomy may be useful as the first line of procedure for biliary access to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) based on recent clinical data. We aimed to evaluate the safety, effectiveness, and feasibility of primary needle knife sphincterotomy (NKS) for biliary cannulation in patients with a high risk of PEP. A total of 40 patients who need ERCP using primary NKS for biliary disease in our institution between June 2018 and November 2019 were prospectively enrolled in this study. The procedures were conducted by two expert biliary endoscopists (S.J. and J.S.P.) who had experience of ERCPs. They had one or more of the following risk factors of PEP; young age (<50 years), female gender, normal common bile duct (CBD) diameter (≤9 mm), normal serum total bilirubin level (0.2-1.2 mg/dL), obesity (body mass index: >30), or history of pancreatitis. The success rate of biliary cannulation, time to biliary cannulation, and the occurrence rate of PEP, as well as other post-ERCP complications, were assessed. Of 40 patients enrolled, 34 patients underwent primary NKS. Nine patients had 1 risk factor of PEP, seven had 2, eight had 3, seven had 4, and three had 5. The success rate of CBD cannulation using NKS was 94.1% (32/34). The median time for biliary cannulation was 243 seconds (range, 32-1,514 seconds). None of the patients experienced post-ERCP pancreatitis, cholangitis, and perforation. One case of minor bleeding (2.9%, 1/34) and 1 asymptomatic hyperamylasemia (2.9%, 1/34) occurred. Primary NKS might be safe, effective and feasible for biliary access in patients with high risk for PEP if the procedure is performed by expert hands.

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