Yamao Kentaro, Kitano Masayuki, Chiba Yasutaka, Ogura Takeshi, Eguchi Takaaki, Moriyama Ichiro, Yamashita Yukitaka, Kato Hironari, Kayahara Takahisa, Hoki Noriyuki, Okabe Yoshinobu, Shiomi Hideyuki, Nakai Yoshitaka, Kushiyama Yoshinori, Fujimoto Yoshifumi, Hayashi Shiro, Bamba Shigeki, Kudo Yasushi, Azemoto Nobuaki, Ueki Toshiharu, Uza Norimitsu, Asada Masanori, Matsumoto Kazuya, Nebiki Hiroko, Takihara Hiroshi, Noguchi Chisio, Kamada Hideki, Nakase Kojiro, Goto Daisuke, Sanuki Tsuyoshi, Koga Tetsuya, Hashimoto Shinichi, Nishikiori Hidefumi, Serikawa Masahiro, Hanada Keiji, Hirao Ken, Ohana Masaya, Kazuyuki Imakiire, Kato Takao, Yoshida Motoyuki, Kawamoto Hirofumi
Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine Hospital, Osakasayama, Osaka, Japan.
Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine Hospital, Osakasayama, Osaka, Japan
Gut. 2021 Jul;70(7):1244-1252. doi: 10.1136/gutjnl-2020-320775. Epub 2020 Nov 22.
Stenting is an established endoscopic therapy for malignant gastric outlet obstruction (mGOO). The choice of stent (covered vs uncovered) has been examined in prior randomised studies without clear results.
In a multicentre randomised prospective study, we compared covered (CSEMS) with uncovered self-expandable metal stents (UCSEMS) in patients with mGOO; main outcomes were stent dysfunction and patient survival, with subgroup analyses of patients with extrinsic and intrinsic tumours.
Overall survival was poor with no difference between groups (probability at 3 months 49.7% for covered vs 48.4% for uncovered stents; log-rank for overall survival p=0.26). Within that setting of short survival, the proportion of stent dysfunction was significantly higher for uncovered stents (35.2% vs 23.4%, p=0.01) with significantly shorter time to stent dysfunction. This was mainly relevant for patients with extrinsic tumours (stent dysfunction rates for uncovered stents 35.6% vs 17.5%, p<0.01). Subgrouping was also relevant with respect to tumour ingrowth (lower with covered stents for intrinsic tumours; 1.6% vs 27.7%, p<0.01) and stent migration (higher with covered stents for extrinsic tumours: 15.3% vs 2.5%, p<0.01).
Due to poor patient survival, minor differences between covered and uncovered stents may be less relevant even if statistically significant; however, subgroup analysis would suggest to use covered stents for intrinsic and uncovered stents for extrinsic malignancies.
支架置入术是治疗恶性胃出口梗阻（mGOO）的一种成熟的内镜治疗方法。先前的随机研究已对覆膜支架与非覆膜支架的选择进行了探讨，但结果并不明确。
在一项多中心随机前瞻性研究中，我们比较了mGOO患者使用覆膜自膨式金属支架（CSEMS）与非覆膜自膨式金属支架（UCSEMS）的情况；主要结局为支架功能障碍和患者生存率，并对外部肿瘤和内部肿瘤患者进行了亚组分析。
总体生存率较差，两组之间无差异（3个月时覆膜支架的生存率为49.7%，非覆膜支架为48.4%；总体生存的对数秩检验p=0.26）。在这种短期生存的情况下，非覆膜支架的支架功能障碍比例显著更高（35.2%对23.4%，p=0.01），且出现支架功能障碍的时间显著更短。这主要与外部肿瘤患者相关（非覆膜支架的支架功能障碍率为35.6%对17.5%，p<0.01）。亚组分析在肿瘤向内生长方面也有意义（内部肿瘤患者中覆膜支架的发生率较低；1.6%对27.7%，p<0.01）以及支架移位方面（外部肿瘤患者中覆膜支架的发生率较高：15.3%对2.5%，p<0.01）。
由于患者生存率较低，覆膜支架与非覆膜支架之间的微小差异即使具有统计学意义，可能也不太重要；然而，亚组分析表明，对于内部恶性肿瘤应使用覆膜支架，对于外部恶性肿瘤应使用非覆膜支架。
