Repici Alessandro, Jovani Manol, Hassan Cesare, Solito Biagio, Di Mitri Roberto, Buffoli Federico, Macrì Giovanni, Fregonese Diego, Cennamo Vincenzo, De Bellis Mario, Anderloni Andrea, Siersema Peter D
Humanitas Research Hospital, Rozzano, Milan, Italy.
Humanitas Research Hospital, Rozzano, Milan, Italy.
Dig Liver Dis. 2014 Dec;46(12):1093-8. doi: 10.1016/j.dld.2014.08.037. Epub 2014 Sep 26.
The majority of currently available oesophageal metal stents are partially covered to reduce migration risk. Preliminary experiences with fully covered stents seem to indicate an increased risk of migration in patients treated for malignant dysphagia. The aim of our study was to determine, in this setting, the safety and efficacy of a new, recently introduced stent with anti-migration proprieties.
We designed a prospective, multicentre, non-randomized, follow-up study in nine tertiary referral centres. Eighty-two patients with dysphagia due to inoperable or metastatic oesophageal cancer were included. In all of them the fully covered WallFlex(®) stent was placed. Main outcome measurements included functional outcome, recurrent dysphagia, complications, and mortality.
Dysphagia score improved from a median of 3, before stenting, to 1 at 4 weeks after stent placement (P<0.001). Perforation occurred in 1 patient after 39 days, while bleeding was reported in 3. In total, 19 patients (23.1%) developed recurrent dysphagia because of stent migration (N=10, 12.2%), tissue overgrowth (N=7; 8.5%), and food impaction (N=2; 2.4%).
Placement of the fully covered WallFlex(®) stent resulted in safe and effective palliation of malignant dysphagia, with migration and tissue overgrowth rates comparable to previously reported data on partially covered stents.
目前大多数可用的食管金属支架为部分覆膜，以降低移位风险。对全覆膜支架的初步经验似乎表明，在接受恶性吞咽困难治疗的患者中，移位风险增加。我们研究的目的是在此情况下确定一种新的、最近推出的具有抗移位特性的支架的安全性和有效性。
我们在9个三级转诊中心设计了一项前瞻性、多中心、非随机的随访研究。纳入82例因无法手术或转移性食管癌导致吞咽困难的患者。所有患者均置入全覆膜WallFlex（®）支架。主要观察指标包括功能结局、复发性吞咽困难、并发症和死亡率。
吞咽困难评分从支架置入前的中位数3分改善至支架置入后4周时的1分（P<0.001）。1例患者在39天后发生穿孔，3例报告有出血。共有19例患者（23.1%）因支架移位（n=10，12.2%）、组织过度生长（n=7；8.5%）和食物嵌塞（n=2；2.4%）出现复发性吞咽困难。
置入全覆膜WallFlex（®）支架可安全有效地缓解恶性吞咽困难，其移位和组织过度生长发生率与先前报道的部分覆膜支架的数据相当。
