A randomized prospective comparison of self-expandable plastic stents and partially covered self-expandable metal stents in the palliation of malignant esophageal dysphagia
A randomized prospective comparison of self-expandable plastic stents and partially covered self-expandable metal stents in the palliation of malignant esophageal dysphagia
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DOI：
10.1111/j.1572-0241.2007.01565.x
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发表时间：
2007-12-01
影响因子：
9.8
通讯作者：
Filiberti, Rosangela
中科院分区：
文献类型：
--
作者：
Conio, Massimo;Repici, Alessandro;Filiberti, Rosangela
目的：自膨式金属支架（SEMS）为恶性吞咽困难患者提供了有效的缓解，尽管可能导致严重的并发症和死亡率。我们进行了一项前瞻性对照试验，比较了一种新的自膨式聚酯网状支架（Polyflex）与SEMS（Ultraflex）。方法：101例不可切除的食管癌患者随机接受Polyflex（N = 47）或部分覆膜Ultraflex（N = 54）支架置入。排除食管胃交界处（EGJ）恶性肿瘤患者。结果：46例（98%）使用Polyflex支架的患者和54例（100%）使用Ultraflex支架的患者成功置入。在1例患者中，无法置入Polyflex支架。1周后，Polyflex组100%和Ultraflex组94%的吞咽困难改善至少1级。在Polyflex组中观察到48%的严重并发症，在Ultraflex组中观察到33%的严重并发症。1例Polyflex和1例Ultraflex患者发生术中穿孔。2名Polyflex患者发生术后出血。20例（44%）使用Polyflex支架的患者和18例（33%）使用Ultraflex支架的患者因肿瘤过度生长、支架移位、增生性肉芽肿反应或食物团嵌塞而复发性吞咽困难。多变量分析显示，Polyflex支架的并发症发生率显著高于Ultraflex支架（比值比2.3，95% CI 1.2-4.4）。然而，Polyflex支架的中位生存期为134天，Ultraflex支架的中位生存期为122天（P = NS）。结论：两种支架在吞咽困难缓解方面无差异。在Polyflex组中观察到明显更多的并发症，尤其是晚期支架移位。
OBJECTIVES: Self-expanding metal stents (SEMS) provide effective palliation in patients with malignant dysphagia, although severe complications and mortality may result. We performed a prospective controlled trial to compare a new self-expanding polyester mesh stent (Polyflex) with SEMS (Ultraflex).METHODS: One hundred one patients with unresectable esophageal carcinoma were randomized to placement of a Polyflex (N = 47) or a partially covered Ultraflex (N = 54) stent. Patients with esophagogastric junction (EGJ) malignancy were excluded.RESULTS: Placement was successful in 46 (98%) patients with the Polyflex and 54 (100%) patients with the Ultraflex stent. In one patient, the Polyflex stent could not be placed. After 1 wk, dysphagia was improved by at least 1 grade in 100% of the Polyflex group and in 94% of the Ultraflex group. Major complications were observed in 48% of the Polyflex group and 33% of the Ultraflex group. Intraprocedural perforation occurred in 1 Polyflex and 1 Ultraflex patient. Two Polyflex patients had postprocedural hemorrhage. Twenty (44%) patients with a Polyflex stent and 18 (33%) with an Ultraflex stent had recurrent dysphagia because of tumor overgrowth, stent migration, hyperplastic granulomatous reaction, or food bolus impaction. Multivariate analysis showed a significantly higher complication rate with Polyflex than with Ultraflex stents (odds ratio 2.3, 95% CI 1.2-4.4). However, median survival was 134 days with Polyflex and 122 days with Ultraflex stents (P = NS).CONCLUSIONS: No difference was seen in palliation of dysphagia between the two stents. Significantly more complications, especially late stent migration, were observed in the Polyflex group.