Sadeghi Amir, Arabpour Erfan, Movassagh-Koolankuh Shahryar, Rastegar Reyhaneh, Moghadam Pardis Ketabi, Omidvari Samareh, Alizadeh Mehrnoosh, Zali Mohammad Reza
Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran .
Clin Transl Gastroenterol. 2024 Dec 1;15(12):e00788. doi: 10.14309/ctg.0000000000000788.
The morphology of the major papilla plays a crucial role in the selection of the cannulation method for the common bile duct during endoscopic retrograde cholangiopancreatography. Nevertheless, there is limited evidence available that compares the efficacy and safety of cannulation approaches in certain papilla morphologies. The aim of this study was to assess the safety and effectiveness of 2 cannulation methods, including primary needle-knife fistulotomy (pNKF) and standard transpapillary (STP), in patients with long-size papilla.
A total of 260 patients with intact long-size papilla were enrolled and were randomly assigned to the pNKF or STP groups (n = 130 in each group). The primary endpoint was the rate of postendoscopic retrograde cholangiopancreatography pancreatitis. Biliary cannulation success rates, the duration of cannulation and the overall procedure, and the incidence of adverse events were also compared between the groups. All of the patients were hospitalized for at least 24 hours after the procedure.
A total of 125 (96.2%) patients in the pNKF and 114 (87.7%) patients in the STP groups had successful primary biliary cannulation ( P = 0.01) and were included in the final analysis. Postendoscopic retrograde cholangiopancreatography pancreatitis occurred in 11 patients in the STP group and 3 patients in the pNKF group (9.6% vs 2.4%, P = 0.02; number needed to treat [95% confidence interval] = 13.9 [7.5-83.2]). Moreover, compared with the pNKF, STP was associated with more cannulation attempts (3.4 vs 2.5, P < 0.001) and longer cannulation time (258 vs 187 seconds, P < 0.001).
In patients with long-size papilla, pNKF is a safer, easier, and more efficient approach to gain primary biliary access than the STP technique.
在经内镜逆行胰胆管造影术中，主乳头的形态在胆总管插管方法的选择中起着关键作用。然而，关于比较某些乳头形态下插管方法的有效性和安全性的证据有限。本研究的目的是评估两种插管方法，即原发性针刀瘘管切开术（pNKF）和标准经乳头插管术（STP），在长型乳头患者中的安全性和有效性。
共纳入260例长型乳头完整的患者，并随机分为pNKF组或STP组（每组130例）。主要终点是内镜逆行胰胆管造影术后胰腺炎的发生率。还比较了两组之间的胆管插管成功率、插管持续时间和整个手术过程以及不良事件的发生率。所有患者在手术后至少住院24小时。
pNKF组共有125例（96.2%）患者和STP组114例（87.7%）患者成功进行了原发性胆管插管（P = 0.01），并纳入最终分析。STP组有11例患者发生内镜逆行胰胆管造影术后胰腺炎，pNKF组有3例患者发生（9.6%对2.4%，P = 0.02；治疗所需人数[95%置信区间]= 13.9 [7.5 - 83.2]）。此外，与pNKF相比，STP的插管尝试次数更多（3.4次对2.5次，P < 0.001），插管时间更长（258秒对187秒，P < 0.001）。
在长型乳头患者中，与STP技术相比，pNKF是一种更安全、更容易且更有效的获得原发性胆管通路的方法。
