全覆膜与部分覆膜自膨式金属支架治疗恶性食管狭窄的功能障碍预测因素：一项为期10年的多中心研究。
Predictors of dysfunction in fully versus partially covered self-expanding metal stents for malignant esophageal strictures: a 10-year multicenter study.
文献信息
| PMID | 42816831 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Özlem Çelebi |
| 作者单位 | Department of Hepatology and Gastroenterology, Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum (CVK) and Campus Charité Mitte (CCM), Berlin, Germany. |
| 期刊 | BMC gastroenterology |
| SCI 分区 | Q2 |
| IF | 3.1 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 鼻科 |
中文摘要
背景： 食管自膨式金属支架（SEMS）可有效恢复恶性梗阻患者的口服摄入，但支架功能障碍仍是常见的临床挑战。我们旨在识别并比较全覆膜与部分覆膜自膨式金属支架（fcSEMS与pcSEMS）支架功能障碍的预测因素。
方法： 这项多中心回顾性队列纳入2014年至2023年间因恶性食管狭窄接受SEMS置入的患者。支架功能障碍包括移位、肿瘤过度生长或食团嵌塞。排除良性或吻合口狭窄、既往消融治疗或未覆膜SEMS的患者。采用累积发病率和Fine-Gray亚分布风险模型，将死亡视为竞争事件。交互项评估支架类型的效应修饰。
结果： 在249例筛选患者中，纳入188例（平均年龄68.0±10.7岁；78.7%为男性；92例pcSEMS和96例fcSEMS）；技术成功率为97.3%。功能障碍发生率为29.8%，fcSEMS比pcSEMS更常见（36.5% vs. 22.8%；p=0.04），主要由于移位（31.3% vs. 10.9%；p<0.01）。在12个月内，37例患者（19.7%）在发生功能障碍前死亡，并作为竞争事件处理。在调整后的Fine-Gray模型中，其他恶性肿瘤（非鳞状/非腺癌）引起的狭窄与fcSEMS组功能障碍强烈相关（sHR 6.53；95% CI 2.51-16.98；p<0.01），且支架类型存在显著效应修饰（sHR交互作用14.1；95% CI 2.08-95.8；p<0.01）。较大的狭窄直径独立预测fcSEMS的功能障碍（每毫米sHR 1.21；95% CI 1.01-1.45；p=0.04），而食管下段位置显示边缘性关联（sHR 2.33；95% CI 0.89-6.07；p=0.08）。不良事件发生率相当（35.9% vs. 43.8%；p=0.27）。
结论： fcSEMS与pcSEMS的支架功能障碍模式不同。肿瘤病因和狭窄解剖结构可能指导风险分层支架选择，并有助于减少再干预。
试验注册： 不适用。
英文摘要
BACKGROUND: Esophageal self-expanding metal stents (SEMS) effectively restore oral intake in malignant obstruction, yet stent dysfunction remains a frequent clinical challenge. We aimed to identify and compare predictors of stent dysfunction in fully versus partially covered self-expanding metal stents (fcSEMS vs. pcSEMS).
METHODS: This multicenter retrospective cohort included patients undergoing SEMS placement for malignant esophageal strictures between 2014 and 2023. Stent dysfunction comprised migration, tumor overgrowth, or food bolus impaction. Patients with benign or anastomotic strictures, prior ablative therapy, or uncovered SEMS were excluded. Cumulative incidence and Fine-Gray subdistribution hazard models were used, treating death as a competing event. Interaction terms assessed effect modification by stent type.
RESULTS: Of 249 screened patients, 188 were included (mean age 68.0 ± 10.7 years; 78.7% male; 92 pcSEMS and 96 fcSEMS); technical success was 97.3%. Dysfunction occurred in 29.8% and was more frequent with fcSEMS than pcSEMS (36.5% vs. 22.8%; p = 0.04), primarily due to migration (31.3% vs. 10.9%; p < 0.01). Within 12 months, 37 patients (19.7%) died before dysfunction and were treated as competing events. In adjusted Fine-Gray models, strictures caused by other malignancies (non-squamous/non-adenocarcinoma) were strongly associated with dysfunction in the fcSEMS group (sHR 6.53; 95% CI 2.51-16.98; p < 0.01), with significant effect modification by stent type (sHR interaction 14.1; 95% CI 2.08-95.8; p < 0.01). Larger stricture diameter independently predicted dysfunction with fcSEMS (sHR per mm 1.21; 95% CI 1.01-1.45; p = 0.04), while lower esophageal location showed a borderline association (sHR 2.33; 95% CI 0.89-6.07; p = 0.08). Adverse-event rates were comparable (35.9% vs. 43.8%; p = 0.27).
CONCLUSION: Patterns of stent dysfunction differed between fcSEMS and pcSEMS. Tumor etiology and stricture anatomy may guide risk-stratified stent selection and help reduce reinterventions.
TRIAL REGISTRATION: Not applicable.