Kawai Junichi, Ogura Takeshi, Takenaka Mamoru, Shiomi Hideyuki, Ueshima Kazuya, Ueno Saori, Okuda Atsushi, Matsuno Jun, Minaga Kousuke, Omoto Shunsuke, Nakai Atsushi, Ikegawa Takuya, Hakoda Akitoshi, Higuchi Kazuhide
TSOZ Pancreatobiliary Study Group, Osaka, Japan.
2nd Department of Internal Medicine, Osaka Medical College, Osaka, Japan.
J Hepatobiliary Pancreat Sci. 2022 Nov;29(11):1195-1203. doi: 10.1002/jhbp.1009. Epub 2021 Jun 30.
Bilateral stent deployment for malignant biliary obstruction (MHBO) can be achieved using side-by-side (SBS) or stent-in-stent (SIS) procedures. Compared with SBS techniques, the procedural steps of SIS are technically complex due to the necessity of introducing the delivery system into a contralateral biliary tract through the mesh of the SEMS. To overcome this issue, a novel uncovered SEMS, the HILZO Moving Cell Stent (MCS) has been released. The present study examined the technical feasibility of treating MHBO using bilateral deployment of this novel stent without dilating the mesh of the first stent to achieve insertion of the second stent within a single session, using a prospective, multicenter setting.
The primary outcome in the present study was the technical success rate. Technical success was defined as deployment of bilateral MCSs into two or more biliary tracts using SIS without a dilation device in a single-session.
A total of 27 patients with complications of MHBO were enrolled in this study. Bilateral SIS using two MCS was successfully performed in 23 patients without using dilation devices among 27 patients (initial technical success rate; 85.2%). Median time to recurrent biliary obstruction (TRBO) was 271 days. Stent dysfunction was observed in 12 patients (44.4%), and re-intervention was successfully performed in all patients without one patient who instead received best supportive care.
The SIS technique using MCS without dilation of the mesh may be technically feasible and safe. In addition, this may be useful for re-intervention. Further comparative randomized trials are needed.
恶性胆管梗阻（MHBO）的双侧支架置入可通过并排（SBS）或支架套支架（SIS）操作来实现。与SBS技术相比，SIS的操作步骤在技术上更为复杂，因为需要通过自膨式金属支架（SEMS）的网孔将输送系统引入对侧胆管。为克服这一问题，一种新型裸SEMS，即HILZO移动细胞支架（MCS）已问世。本研究采用前瞻性、多中心研究方法，探讨在单次手术中不扩张首个支架的网孔以实现第二个支架置入的情况下，使用这种新型支架双侧置入治疗MHBO的技术可行性。
本研究的主要结局是技术成功率。技术成功定义为在单次手术中不使用扩张装置通过SIS将双侧MCS置入两个或更多胆管。
本研究共纳入27例MHBO并发症患者。27例患者中有23例在未使用扩张装置的情况下成功进行了使用两个MCS的双侧SIS（初始技术成功率为85.2%）。复发性胆管梗阻（TRBO）的中位时间为271天。12例患者（44.4%）出现支架功能障碍，所有患者均成功进行了再次干预，无一例患者接受最佳支持治疗。
不扩张网孔使用MCS的SIS技术在技术上可能是可行且安全的。此外，这可能对再次干预有用。需要进一步的比较随机试验。
