Sampaziotis Fotios, Elias Joshua, Gelson William T H, Gimson Alexander E, Griffiths William J H, Woodward Jeremy, Shariff Mohamed, Macfarlane Bruce, King Alistair, Corbett Gareth, Leahy Anthony
Departments of aHepatology bGastroenterology, Cambridge University Hospitals NHS Foundation Trust cAnne McLaren Laboratory for Regenerative Medicine, Department of Surgery, Wellcome Trust-Medical Research Council Stem Cell Institute, University of Cambridge, Cambridge dDepartment of Gastroenterology, West Hertfordshire Hospitals NHS Trust, Hertfordshire, UK.
Eur J Gastroenterol Hepatol. 2015 Nov;27(11):1347-53. doi: 10.1097/MEG.0000000000000455.
Fully covered self-expanding metal stents (FCSEMS) constitute the first type of metal stent that can easily be removed endoscopically and/or intraoperatively, which may be advantageous in the management of distal malignant biliary strictures (DMBS). To assess the efficacy of FCSEMS as first-line treatment for DMBS, we compared patency, survival and complication rates between FCSEMS, uncovered self-expanding metal stents (USEMS) and plastic stents (PS).
This was a multicentre retrospective study of 315 consecutive patients with DMBS, who underwent endoscopic retrograde cholangiopancreatography and stenting (FCSEMS, USEMS or PS) at two hospitals between 1 January 2007 and 31 December 2013. Stent patency and patient survival were compared using the Kaplan-Meier method; complication rates were compared using Fisher's exact test; and Cox regression analysis was used to screen for confounding factors.
FCSEMS were associated with prolonged stent patency (median=145 days) compared with USEMS (median=110 days, P<0.003) and PS (median=34 days, P<0.001). Biliary sepsis rates were lower for FCSEMS compared with PS (4.7 vs. 17.8%, P=0.02), whereas pancreatitis rates were higher for FCSEMS compared with USEMS (7.8 vs. 1.0%, P=0.04), but not PS (2.6%, P=NS).
The use of FCSEMS as first-line management for DMBS is associated with longer patency and reduced complication rates compared with the use of PS. However, the higher rate of pancreatitis compared with USEMS requires further evaluation in a large randomized controlled trial.
全覆膜自膨式金属支架（FCSEMS）是第一种能够在内镜下和/或手术中轻松取出的金属支架，这在远端恶性胆管狭窄（DMBS）的治疗中可能具有优势。为评估FCSEMS作为DMBS一线治疗的疗效，我们比较了FCSEMS、裸金属自膨式支架（USEMS）和塑料支架（PS）在通畅率、生存率和并发症发生率方面的差异。
这是一项多中心回顾性研究，纳入了2007年1月1日至2013年12月31日期间在两家医院接受内镜逆行胰胆管造影及支架置入术（FCSEMS、USEMS或PS）的315例连续性DMBS患者。采用Kaplan-Meier法比较支架通畅率和患者生存率；采用Fisher精确检验比较并发症发生率；采用Cox回归分析筛选混杂因素。
与USEMS（中位时间=110天，P<0.003）和PS（中位时间=34天，P<0.001）相比，FCSEMS的支架通畅时间延长（中位时间=145天）。与PS相比，FCSEMS的胆系感染率更低（4.7%对17.8%，P=0.02），而与USEMS相比，FCSEMS的胰腺炎发生率更高（7.8%对1.0%，P=0.04），但与PS相比无差异（2.6%，P=无统计学意义）。
与使用PS相比，将FCSEMS作为DMBS的一线治疗方法可使支架通畅时间更长，并发症发生率降低。然而，与USEMS相比，FCSEMS的胰腺炎发生率较高，需要在大型随机对照试验中进一步评估。
