Lee Hyuk, Min Byung-Hoon, Lee Jeong Hoon, Shin Cheol Min, Kim Younjoo, Chung Hyunsoo, Lee Sang Hyub
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
Am J Gastroenterol. 2015 Oct;110(10):1440-9. doi: 10.1038/ajg.2015.286. Epub 2015 Sep 15.
Previous studies reported comparable stent patency between covered self-expandable metallic stents (SEMS) and uncovered SEMS (UCS) for palliation of malignant gastric outlet obstruction (GOO). The aim of this study was to evaluate the efficacy and safety of the newly developed WAVE-covered SEMS (WCS), which has an anti-migration design, compared with UCS in gastric cancer patients with symptomatic GOO.
A total of 102 inoperable gastric cancer patients with symptomatic GOO were prospectively enrolled from five referral centers and randomized to undergo UCS or WCS placement. Stent patency and recurrence of obstructive symptoms were assessed at 8 weeks and 16 weeks after stent placement.
At the 8-week follow-up, both stent patency rates (72.5% vs. 62.7%) and re-intervention rates (19.6% vs. 19.6%) were comparable between the WCS and the UCS groups. Both stent stenosis (2.4% vs. 8.1%) and migration rates (9.5% vs. 5.4%) were comparable between WCS and UCS groups. At the 16-week follow-up, however, the WCS group had a significantly higher stent patency rate than the UCS group (68.6% vs. 41.2%). Re-intervention rates in the WCS and UCS groups were 23.5% and 39.2%, respectively. Compared with the UCS group, the WCS group had a significantly lower stent restenosis rate (7.1% vs. 37.8%) and a comparable migration rate (9.5% vs. 5.4%). Overall stent patency was significantly longer in the WCS group than in the UCS group. No stent-associated significant adverse events occurred in either the WCS or UCS groups. In the multivariate analysis, WCS placement and chemotherapy were identified as independent predictors of 16-week stent patency.
WCS group showed comparable migration rate and significantly more durable long-term stent patency compared with UCS group for the palliation of GOO in patients with inoperable gastric cancer.
既往研究报道，覆膜自膨式金属支架（SEMS）与非覆膜SEMS（UCS）在缓解恶性胃出口梗阻（GOO）方面的支架通畅率相当。本研究的目的是评估新开发的具有抗迁移设计的WAVE覆膜SEMS（WCS）与UCS相比，在有症状的GOO胃癌患者中的疗效和安全性。
从五个转诊中心前瞻性纳入102例有症状的不可手术胃癌GOO患者，随机接受UCS或WCS置入。在支架置入后8周和16周评估支架通畅情况和梗阻症状复发情况。
在8周随访时，WCS组和UCS组的支架通畅率（72.5%对62.7%）和再次干预率（19.6%对19.6%）相当。WCS组和UCS组的支架狭窄率（2.4%对8.1%）和迁移率（9.5%对5.4%）相当。然而，在16周随访时，WCS组的支架通畅率显著高于UCS组（68.6%对41.2%）。WCS组和UCS组的再次干预率分别为23.5%和39.2%。与UCS组相比，WCS组的支架再狭窄率显著更低（7.1%对37.8%），迁移率相当（9.5%对5.4%）。WCS组的总体支架通畅时间显著长于UCS组。WCS组和UCS组均未发生与支架相关重大不良事件。在多因素分析中，WCS置入和化疗被确定为16周支架通畅的独立预测因素。
对于不可手术胃癌患者的GOO缓解，WCS组与UCS组相比迁移率相当，长期支架通畅性显著更持久。
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