Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.
Department of Gastroenterology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.
Eur Radiol. 2020 Jan;30(1):175-185. doi: 10.1007/s00330-019-06374-7. Epub 2019 Aug 5.
To investigate whether covered stents show a higher efficacy than uncovered stents in percutaneous treatment of malignant hilar biliary obstruction.
Patients with obstructive jaundice caused by an unresectable hilar malignancy were included after failed endoscopic intervention in a prospective randomized trial comparing expanded polytetrafluoroethylene and fluorinated ethylene propylene (ePTFE-FEP)-covered nitinol stents with uncovered nitinol stents. Exclusion criteria were as follows: primary tumors existing more than 3 months, a biliodigestive anastomosis, previous stenting, and a Karnofsky score of less than 50. Safety, clinical success, and adjuvant chemotherapy were compared as well as occlusion rate, patency, and survival.
A total of 120 patients were included. One patient was post hoc excluded. Fourteen patients who died within 7 days and one patient without patency data were excluded from patency analysis. Serious adverse events (p = 0.4), 30-day mortality (p = 0.5), and clinical success (p = 0.8) were equivalent for both stent groups. Twenty-one out of 61 (34%) patients in the covered and 24/58 (41%) in the uncovered stent groups received adjuvant chemotherapy (p = 0.5). Occlusion rate was 54% (27/50) in the covered stent group and 57% (31/54) in the uncovered stent group (p = 0.8). Median patency was 229 days (95% CI 113-345) for covered stents and 130 days (95% CI 75-185) for uncovered stents (p = 0.1). Median survival in patients with covered stents was 79 days (95% CI 52-106) and with uncovered stents 92 days (95% CI 60-124) (p = 0.3).
In malignant hilar biliary obstruction, there is no evidence that ePTFE-FEP-covered stents are superior to uncovered stents in terms of safety, clinical success, adjuvant chemotherapy, patency, or survival.
• Percutaneous palliation of hilar biliary obstruction is feasible with both uncovered and covered stents. • Clinical success in terms of bilirubin decrease and adjuvant chemotherapy is achievable with both stents. • Thirty-day mortality is considerable when stenting is also offered to patients with a low performance status.
探讨覆膜支架与未覆膜支架在经皮治疗不可切除肝门部恶性胆道梗阻中的疗效差异。
前瞻性随机试验纳入内镜治疗失败的不可切除肝门部恶性肿瘤所致梗阻性黄疸患者，比较扩张聚四氟乙烯（ePTFE）-氟乙烯丙烯（FEP）覆膜和未覆膜镍钛合金支架的疗效。排除标准为：原发肿瘤存在时间超过 3 个月、胆肠吻合、既往支架置入和卡氏功能状态评分（KPS）<50。比较安全性、临床疗效和辅助化疗，以及闭塞率、通畅率和生存率。
共纳入 120 例患者，1 例患者因事后发现存在禁忌证而被排除。14 例患者在 7 天内死亡，1 例患者无通畅数据，这 15 例患者被排除在通畅率分析之外。覆膜支架组和未覆膜支架组严重不良事件（p=0.4）、30 天死亡率（p=0.5）和临床疗效（p=0.8）相当。覆膜支架组 21 例（34%）和未覆膜支架组 24 例（41%）患者接受了辅助化疗（p=0.5）。覆膜支架组闭塞率为 54%（27/50），未覆膜支架组为 57%（31/54）（p=0.8）。覆膜支架组中位通畅时间为 229 天（95%CI 113-345），未覆膜支架组为 130 天（95%CI 75-185）（p=0.1）。覆膜支架组中位生存时间为 79 天（95%CI 52-106），未覆膜支架组为 92 天（95%CI 60-124）（p=0.3）。
在恶性肝门部胆道梗阻中，覆膜支架在安全性、临床疗效、辅助化疗、通畅率和生存率方面并不优于未覆膜支架。
• 经皮肝门部胆道支架置入术对未覆膜和覆膜支架均可行。
• 两种支架均能降低胆红素并进行辅助化疗，实现临床疗效。
• 对于 KPS 评分较低的患者，支架置入术也会增加 30 天死亡率。
