Placement of a self-expandable metal stent (SEMS) across the duodenal major papilla carries a risk of duodenobiliary reflux (DBR). The suprapapillary method of stent placement may reduce DBR and improve stent patency compared with the transpapillary method. This study compared the clinical outcomes between the suprapapillary and transpapillary methods for distal malignant biliary obstruction (DMBO). Between January 2021 and January 2023, consecutive patients with DMBO from 6 centers in South Korea were randomly assigned to either the suprapapillary arm or transpapillary method arm in a 1:1 ratio. The primary outcome was the duration of stent patency, and secondary outcomes were the cause of stent dysfunction, adverse events, and overall survival rate. Eighty-four patients were equally assigned to each group. The most common cause of DMBO was pancreatic cancer (50, 59.5%), followed by bile duct (20, 23.8%), gallbladder (11, 13.1%), and other cancers (3, 3.6%). Stent patency was significantly longer in the suprapapillary group (median, 369 days [interquartile range, 289-497] vs 154 days [interquartile range, 78-361]; < .01). Development of DBR was significantly lower in the suprapapillary group (9.4% vs 40.8%, < .01). Adverse events and overall survival rate were not significantly different between the 2 groups. The placement of SEMSs using the suprapapillary method resulted in a significantly longer duration of stent patency. It is advisable to place the SEMS using the suprapapillary method in DMBO. Further studies with a larger number of patients are required to validate the benefits of the suprapapillary method. (Clinical trial registration number: KCT0005572.)

中文翻译：

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乳头上法对远端恶性胆道梗阻通畅的影响：多中心随机对照试验


在十二指肠大乳头放置自扩张金属支架 (SEMS) 会带来十二指肠胆反流 (DBR) 的风险。与经乳头法相比，乳头上支架置入法可降低 DBR 并提高支架通畅性。本研究比较了乳头上法和经乳头法治疗远端恶性胆道梗阻 (DMBO) 的临床结果。 2021 年 1 月至 2023 年 1 月期间，来自韩国 6 个中心的连续 DMBO 患者以 1:1 的比例随机分配至乳头上法组或经乳头法组。主要结局是支架通畅的持续时间，次要结局是支架功能障碍的原因、不良事件和总生存率。 84 名患者被平均分配到每组。 DMBO最常见的原因是胰腺癌（50例，59.5%），其次是胆管癌（20例，23.8%）、胆囊癌（11例，13.1%）和其他癌症（3例，3.6%）。上乳头组的支架通畅时间明显更长（中位时间为 369 天 [四分位间距，289-497] vs 154 天 [四分位间距，78-361]；< .01）。乳头上组中 DBR 的发生率显着较低（9.4% vs 40.8%，< .01）。两组之间的不良事件和总生存率没有显着差异。使用毛细管上方法放置 SEMS 可以显着延长支架的通畅时间。建议使用毛细管上法将 SEMS 放置在 DMBO 中。需要对大量患者进行进一步研究来验证乳头上方法的益处。 （临床试验注册号：KCT0005572。）