Ishida Yuki, Hisa Takeshi, Matsumoto Ryusuke, Nishiyama Shigeru, Kudo Akiharu, Yamada Takahiro, Osera Shozo, Tomori Akihisa, Fukushima Hideki
Department of Gastroenterology, Saku Central Hospital Advanced Care Center, Nagano, Japan.
Department of Gastroenterology, Matsumoto Kyoritsu Hospital, Nagano, Japan.
J Hepatobiliary Pancreat Sci. 2025 Feb;32(2):160-167. doi: 10.1002/jhbp.12097. Epub 2024 Dec 11.
Endoscopic sphincterotomy (ES) for bile duct stones (BDS) can cause basket impaction with stone, complicating the procedure. In this study, we evaluated the utility and safety of small incision ES combined with endoscopic papillary balloon dilation (sES + EPBD) (balloon dilated up to the stone size), compared with ES alone for BDS <12 mm.
The primary endpoint was the frequency of mechanical lithotripsy (ML), indicating the risk of basket impaction with stone; however, the secondary endpoints were procedure time, successful stone removal, and early adverse events.
A total of 100 patients were randomized into the ES and sES + EPBD groups (n = 50 for each). Significantly fewer cases required ML (20.0% vs. 4.0%, p = .028) in the sES + EPBD group. The maximum short-axis diameter of the stones in all patients requiring ML in the ES group ranged from 8 to 11 mm. The median procedure time was significantly shorter (18.5 min vs. 17 min, p = .047) in the sES + EPBD group. Both groups showed similar frequencies of successful stone removal in one session (88.0% vs. 98.0%, p = .112) and early adverse events (4.0% vs. 2.0%, p = .62).
In cases of small BDS, sES + EPBD exhibits a low frequency of ML, which shortens procedure time and prevents basket impaction with stones.
内镜下括约肌切开术（ES）治疗胆管结石（BDS）可导致结石嵌顿于取石篮，使手术复杂化。在本研究中，我们评估了小切口ES联合内镜乳头球囊扩张术（sES + EPBD）（球囊扩张至结石大小）与单纯ES治疗直径<12 mm的BDS的有效性和安全性。
主要终点是机械碎石术（ML）的频率，表明结石嵌顿于取石篮的风险；然而，次要终点是手术时间、结石清除成功率和早期不良事件。
总共100例患者被随机分为ES组和sES + EPBD组（每组n = 50）。sES + EPBD组需要ML的病例明显更少（20.0%对4.0%，p = 0.028）。ES组所有需要ML的患者结石的最大短轴直径范围为8至11 mm。sES + EPBD组的中位手术时间明显更短（18.5分钟对17分钟，p = 0.047）。两组在一次手术中结石清除成功的频率（88.0%对98.0%，p = 0.112）和早期不良事件（4.0%对2.0%，p = 0.62）相似。
在小BDS病例中，sES + EPBD表现出较低的ML频率，可缩短手术时间并防止结石嵌顿于取石篮。
