Catalano Marc F, Geenen Joseph E, Lehman Glen A, Siegel Jerome H, Jacob Leslie, McKinley Matthew J, Raijman Isaac, Meier Peter, Jacobson Ira, Kozarek Richard, Al-Kawas Firas H, Lo Simon K, Dua Kulwinder S, Baille John, Ginsberg Gregory G, Parsons William, Meyerson Scott M, Cohen Seth, Nelson Douglas B, McHattie James D, Carr-Locke David L
Pancreatic Biliary Center, St. Luke's Medical Center, Milwaukee, WI 53215, USA.
Gastrointest Endosc. 2002 Mar;55(3):354-8. doi: 10.1067/mge.2002.121879.
Premature stent clogging is the major limitation with plastic stents used in the treatment of malignant biliary structures. A pilot study suggested improved duration of patency of the Tannenbaum stent compared with polyethylene stents. The aim of this prospective, multicenter randomized trial was to compare the Tannenbaum Teflon stent with a conventional polyethylene endoprosthesis (Cotton-Leung biliary stent set) for the treatment of malignant biliary strictures.
Patients over age 18 years with symptoms caused by nonhilar malignant biliary strictures were enrolled. Patients were randomized to receive a 10F Tannenbaum or polyethylene stent after a guidewire was passed beyond the stricture. One hundred six patients (mean age 72 years and 71 years, respectively) were enrolled (54 Tannenbaum, mean age 72 years; 52 polyethylene, mean age 71 years).
Tannenbaum and polyethylene stent placement was successful in, respectively, 100% and 96% of procedures without complications. The mean (SD) 90-day stent patency of the Tannenbaum stent was 67% (7%) compared with 73% (7%) for the polyethylene stents.
The present study demonstrated no difference in ease of implantation or stent patency between Tannenbaum and polyethylene stents.
支架过早堵塞是用于治疗恶性胆管狭窄的塑料支架的主要局限性。一项初步研究表明,与聚乙烯支架相比,坦嫩鲍姆支架的通畅持续时间有所改善。这项前瞻性、多中心随机试验的目的是比较坦嫩鲍姆聚四氟乙烯支架与传统聚乙烯内置假体(科顿-梁氏胆道支架套装)在治疗恶性胆管狭窄方面的效果。
纳入年龄在18岁以上、由非肝门部恶性胆管狭窄引起症状的患者。在导丝穿过狭窄部位后,将患者随机分组,分别接受10F坦嫩鲍姆支架或聚乙烯支架。共纳入106例患者(平均年龄分别为72岁和71岁)(54例接受坦嫩鲍姆支架,平均年龄72岁;52例接受聚乙烯支架,平均年龄71岁)。
坦嫩鲍姆支架和聚乙烯支架置入手术的成功率分别为100%和96%,均无并发症。坦嫩鲍姆支架90天的平均(标准差)通畅率为67%(7%),而聚乙烯支架为73%(7%)。
本研究表明,坦嫩鲍姆支架和聚乙烯支架在植入难易程度或支架通畅率方面没有差异。