Background and Aim. Needle-knife sphincterotomy (NKS) is currently recommended as the second option in cases of difficult cannulation due to its potential higher adverse event rate. However, the clinical outcomes of NKS have not been evaluated as thoroughly as those of the primary cannulation technique. The aim of the current study was to investigate the feasibility, efficacy, and safety of NKS when used for primary access in patients at high risk of developing postendoscopic retrograde cholangiopancreatography pancreatitis (PEP). Methods. Forty patients with one or more risk factors for PEP were prospectively enrolled between June 2018 and November 2019. The cannulation was conducted in all patients using NKS as the primary cannulation technique. Success rate of biliary cannulation, biliary cannulation time, and adverse event rate were assessed. Results. Of the 40 patients enrolled, 34 patients underwent primary NKS after the screening. Nine patients had 1 risk factor for PEP, 7 had 2, 8 had 3, 7 had 4, and 3 had 5. The success rate of biliary access by NKS was 94.1% (32/34). The median procedure time for NKS and the total procedure time for stone removal or biliary drainage were 4.1 minutes (range, 0.5-25.2) and 11.3 minutes (range, 3.8–40.4), respectively. Adverse events occurred in two patients (minor bleeding, ; hyperamylasemia, ). No patient experienced PEP or perforation. Conclusion. NKS might be feasible as a primary cannulation procedure in patients at high risk of PEP. This trial is registered with KCT0004886 (03/06/2018).

中文翻译：

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内镜逆行胰胆管造影胰腺炎高危患者的原发性针刀括约肌切开术治疗胆道疾病

背景和目的。由于难治性插管术（NKS）潜在的更高的不良事件发生率，目前建议将其作为第二种选择，以用于难以插管的患者。但是，尚未像常规插管技术那样对NKS的临床结果进行全面评估。本研究的目的是调查在有内镜后逆行胰胆管造影术胰腺炎（PEP）高风险的患者进行初次手术时，NKS的可行性，疗效和安全性。方法。在2018年6月至2019年11月期间，前瞻性招募了40名具有一种或多种PEP危险因素的患者。所有患者均使用NKS作为主要的插管技术进行了插管。评估胆道插管的成功率，胆道插管时间和不良事件发生率。结果。在筛选的40例患者中，有34例接受了原发性NKS治疗。9名患者的PEP危险因素为1、7、2、8、3、7、4和3为5。NKS胆道通路的成功率为94.1％（32/34）。NKS的中位手术时间和结石清除或胆道引流的总手术时间分别为4.1分钟（范围0.5-25.2）和11.3分钟（范围3.8-40.4）。两名患者发生了不良事件（轻微出血，; 高淀粉血症）。没有患者经历过PEP或穿孔。结论。对于高PEP风险的患者，NKS作为主要的插管程序可能是可行的。该试验已向KCT0004886（03/06/2018）注册。