Digestive Endoscopy Unit, Gemelli University Hospital, Università Cattolica del Sacro Cuore, Rome, Italy.
Dig Liver Dis. 2013 Apr;45(4):305-9. doi: 10.1016/j.dld.2012.11.001. Epub 2012 Dec 6.
Biliary partially covered self-expandable metal stents (PC-SEMS) offer prolonged relief of symptoms of biliary obstruction but may induce complications including pancreatitis, cholecystitis and migration.
To assess efficacy and safety of the ComVi partially covered self-expandable metal stents as primary palliative treatment of distal malignant biliary obstruction.
Seventy patients (mean age 69.2 years) with distal malignant biliary strictures were prospectively included and underwent endoscopic retrograde cholangio-pancreatography and partially covered self-expandable metal stents placement. Follow-up was done for 12 months. self-expandable metal stents patency, survival and complication-rate after partially covered self-expandable metal stents placement were evaluated.
Overall median survival time was 190 days (30-856). Forty-four patients (62.8%) died after median 175.5 days (30-614) without signs of stent dysfunction; 37 patients (52.8%) were alive after 6 months without signs of self-expandable metal stents occlusion. Survival rapidly dropped between 8 and 12 months after treatment. Survival was not influenced by sex (P = 0.1) or type of neoplasia (P = 0.178). Median survival was longer (254 days [44-836]) in patients who underwent chemotherapy (P < 0.0001). Partially covered self-expandable metal stents occlusion had 24 (35.7%) patients 154 days (35-485) after treatment. Median survival after re-treatment was 66 days (13-597). Cholecystitis occurred in one patient (1.7%).
The ComVi partially covered self-expandable metal stents is effective for palliation of biliary obstruction secondary to distal malignant biliary strictures. Self-expandable metal stents patency during follow-up is satisfactory without significant complications.
胆道部分覆膜自膨式金属支架（PC-SEMS）能长时间缓解胆道梗阻症状，但可能引发胰腺炎、胆囊炎和支架迁移等并发症。
评估 ComVi 部分覆膜自膨式金属支架作为治疗远端恶性胆道梗阻的一线姑息性治疗方法的疗效和安全性。
70 例（平均年龄 69.2 岁）远端恶性胆道狭窄患者前瞻性纳入并接受内镜逆行胰胆管造影和部分覆膜自膨式金属支架置入术。进行 12 个月的随访。评估支架通畅率、生存时间和并发症发生率。
总体中位生存时间为 190 天（30-856 天）。44 例（62.8%）患者在中位生存期 175.5 天（30-614 天）后死亡，无支架功能障碍迹象；37 例（52.8%）患者在 6 个月后仍存活，无支架闭塞迹象。治疗后 8-12 个月内生存率迅速下降。性别（P=0.1）或肿瘤类型（P=0.178）对生存率无影响。接受化疗的患者中位生存时间较长（254 天[44-836]天，P<0.0001）。支架闭塞发生于 24 例（35.7%）患者，时间为治疗后 154 天（35-485 天）。再次治疗后的中位生存时间为 66 天（13-597 天）。1 例（1.7%）患者发生胆囊炎。
ComVi 部分覆膜自膨式金属支架治疗远端恶性胆道狭窄所致胆道梗阻有效。支架通畅率在随访期间令人满意，无明显并发症。
