Bernon M M, Shaw J, Burmeister S, Chinnery G, Hofmeyr S, Kloppers J C, Jonas E, Krige J Ej
Surgical Gastroenterology and HPB Surgical Unit Department of Surgery, University of Cape Town Health Sciences Faculty, Groote Schuur Hospital, Anzio Road, Observatory 7925, Cape Town, South Africa.
Hepatobiliary Surgery Unit, Division of General Surgery, University of Saskatchewan and Royal University Hospital, Hospital Drive, Saskatoon, Saskatchewan, Canada.
S Afr J Surg. 2018 Mar;56(1):30-34.
The aim of this study was to determine the safety and clinical effectiveness of 10Fr plastic biliary stents compared to uncovered self-expanding metal stents (SEMS) for palliative treatment of patients with inoperable extra-hepatic malignant biliary obstruction in a public hospital in South Africa.
From January 2009 to December 2013, 40 patients who were admitted to a tertiary academic centre because of distal malignant biliary obstruction were enrolled in a prospective randomized study. Patients were randomly assigned to receive an uncovered SEMS or a plastic stent deployed through the biliary stricture during endoscopic retrograde cholangiopancreatography (ERCP).
Patient survival time in the two groups did not differ significantly (median: SEMS - 114 days; plastic - 107 days). Stent failure was more common in the plastic stent group (7/19 vs. 1/21). The results became significant after 6 months of follow-up. There was no significant difference between the two groups in the incidence of serious adverse events.
SEMS had a longer duration of patency than plastic stents, which recommends their use in the palliative treatment of patients with biliary obstruction due to distal malignant biliary obstruction.
本研究旨在比较10Fr塑料胆道支架与裸金属自膨式支架（SEMS）对南非一家公立医院无法手术的肝外恶性胆道梗阻患者进行姑息治疗的安全性和临床疗效。
2009年1月至2013年12月，40例因远端恶性胆道梗阻入住三级学术中心的患者被纳入一项前瞻性随机研究。患者在进行内镜逆行胰胆管造影（ERCP）时被随机分配接受裸金属自膨式支架或通过胆道狭窄置入的塑料支架。
两组患者的生存时间无显著差异（中位数：金属自膨式支架组-114天；塑料支架组-107天）。塑料支架组的支架失败更为常见（7/19比1/21）。随访6个月后结果变得显著。两组严重不良事件的发生率无显著差异。
金属自膨式支架的通畅时间比塑料支架长，这表明它们可用于远端恶性胆道梗阻所致胆道梗阻患者的姑息治疗。
