自膨式金属支架置入术桥接治疗恶性结直肠梗阻：来自两项前瞻性多中心研究的 426 例患者的汇总分析。
Self-expandable metallic stenting as a bridge to surgery for malignant colorectal obstruction: pooled analysis of 426 patients from two prospective multicenter series.
机构信息
Department of Surgery, Kishiwada Tokushukai Hospital, 4-27-1 Kamori-cho, Kishiwada-shi, Osaka, 596-8522, Japan.
Division of Surgery, Gastrointestinal Center, Yokohama Shin-Midori General Hospital, Yokohama, Japan.
出版信息
Surg Endosc. 2019 Feb;33(2):499-509. doi: 10.1007/s00464-018-6324-8. Epub 2018 Jul 13.
BACKGROUND
Self-expandable metallic stenting (SEMS) for malignant colorectal obstruction (MCO) as a bridge to elective surgery (BTS) is a widely used procedure. The aim of this study was to assess short-term outcomes of SEMS for MCO as BTS.
METHODS
This study analyzed pooled data from BTS patients who were enrolled in two multicenter prospective single-arm observational clinical studies that used different stent types. Both studies were conducted by the Japan Colonic Stent Safe Procedure Research Group (JCSSPRG). The first study evaluated the WallFlex™ colonic stent for BTS or palliative treatment (PAL) from May 2012 to October 2013 and the second evaluated the Niti-S™ colonic stent from October 2013 to May 2014. Fifty-three facilities in Japan participated in the studies. Before each study started, the procedure had been shared with the participating institutions by posting details of the standard methods of SEMS placement on the JCSSPRG website. Patients were followed until discharged after surgery.
RESULTS
A total of 723 consecutive patients were enrolled in the two studies. After excluding nine patients, the remaining 714 patients were evaluated as a per-protocol cohort. SEMS placement was performed in 426 patients (312 WallFlex and 114 Niti-S) as BTS and in 288 as PAL. In the 426 BTS patients, the technical success rate was 98.1% (418/426). The clinical success rate was 93.8% (392/418). SEMS-related preoperative complications occurred in 8.5% of patients (36/426), perforations in 1.9% (8/426), and stent migration in 1.2% (5/426). Primary anastomosis was possible in 91.8% of patients (391/426), 3.8% of whom (15/393) had anastomosis leakage. The overall stoma creation rate was 10.6% (45/426). The postoperative complication rate was 16.9% (72/426) and mortality rate was 0.5% (2/426).
CONCLUSIONS
SEMS placement for MCO as BTS is safe and effective with respect to peri-procedural outcomes. Further investigations are needed to confirm long-term oncological outcomes.
背景
自膨式金属支架（SEMS）治疗恶性结直肠梗阻（MCO）作为择期手术（BTS）的桥梁已被广泛应用。本研究旨在评估 SEMS 治疗 MCO 作为 BTS 的短期疗效。
方法
本研究分析了两项多中心前瞻性单臂观察性临床研究中 BTS 患者的汇总数据，这些研究使用了不同类型的支架。两项研究均由日本结直肠支架安全程序研究组（JCSSPRG）开展。第一项研究评估了 WallFlex™结肠支架用于 BTS 或姑息治疗（PAL）的效果，研究时间为 2012 年 5 月至 2013 年 10 月，第二项研究评估了 Niti-S™结肠支架的效果，研究时间为 2013 年 10 月至 2014 年 5 月。日本共有 53 家机构参与了这两项研究。在每项研究开始前，JCSSPRG 网站上公布了 SEMS 放置的标准方法，以向参与机构分享该手术过程。患者在手术后出院前接受随访。
结果
两项研究共纳入 723 例连续患者，排除 9 例患者后，714 例患者被纳入意向治疗人群。426 例（312 例 WallFlex 和 114 例 Niti-S）患者接受 SEMS 治疗作为 BTS，288 例作为 PAL。在 426 例 BTS 患者中，技术成功率为 98.1%（418/426），临床成功率为 93.8%（392/418）。SEMS 相关的术前并发症发生率为 8.5%（36/426），穿孔发生率为 1.9%（8/426），支架移位发生率为 1.2%（5/426）。91.8%（391/426）的患者可进行一期吻合，其中 3.8%（15/393）的患者吻合口漏。总的造口率为 10.6%（45/426）。术后并发症发生率为 16.9%（72/426），死亡率为 0.5%（2/426）。
结论
SEMS 治疗 MCO 作为 BTS 是安全有效的，其围手术期结局良好。需要进一步的研究来证实其长期的肿瘤学疗效。
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