Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.
J Gastroenterol. 2012 Nov;47(11):1248-56. doi: 10.1007/s00535-012-0582-3. Epub 2012 Apr 20.
Although self-expandable metal stents (SEMS) are widely used for distal malignant biliary obstruction, one-step SEMS (direct placement without a prior plastic stent) and two-step SEMS (placement at second endoscopic retrograde cholangiopancreatography [ERCP] following plastic stent placement) have not been fully compared.
In this multicenter retrospective study, patients were included who underwent first-time endoscopic SEMS placement between September 1994 and December 2010. We compared the one-step and two-step strategies using a propensity analysis.
In total, 370 patients were identified and one-step SEMS was performed in 59 patients. After adjustment using propensity scores, the median times to dysfunction were 116 and 219 days, respectively, for one-step and two-step SEMS (P = 0.058). Stent migration was more frequently observed in one-step SEMS as compared with two-step SEMS (25 vs. 11 %, P = 0.031). In one-step SEMS, the number of days of hospitalization associated with first-time SEMS placement was shorter compared with that in two-step SEMS (21 vs. 30 days, P = 0.001), and the total costs of SEMS-related interventions within 6 months were lower (6510 and 8100 USD, P = 0.004). The pathological diagnosis rates for pancreatic and biliary tract cancer at initial ERCP were 52 and 61 %. After failed diagnosis at initial ERCP, pathological diagnosis rates for pancreatic cancer were 32 versus 76 % (P = 0.005) by repeated ERCP versus endoscopic ultrasound (EUS)-guided fine-needle aspiration (FNA).
One-step SEMS was associated with increased stent migration, despite having potential cost-effectiveness. The additional yield of pathological diagnosis at repeated ERCP was low compared with that yielded by EUS-guided FNA.
尽管自膨式金属支架（SEMS）广泛用于治疗远端恶性胆道梗阻，但一步法 SEMS（直接放置而不事先放置塑料支架）和两步法 SEMS（在塑料支架放置后第二次内镜逆行胰胆管造影 [ERCP] 时放置）尚未得到充分比较。
在这项多中心回顾性研究中，纳入了 1994 年 9 月至 2010 年 12 月期间首次接受内镜 SEMS 放置的患者。我们使用倾向评分进行了一步法和两步法策略的比较。
共确定了 370 例患者，其中 59 例患者行一步法 SEMS。经倾向评分调整后，一步法和两步法 SEMS 的功能障碍中位时间分别为 116 天和 219 天（P = 0.058）。与两步法 SEMS 相比，一步法 SEMS 更常发生支架迁移（25%比 11%，P = 0.031）。在一步法 SEMS 中，首次放置 SEMS 的住院天数较两步法 SEMS 更短（21 天比 30 天，P = 0.001），并且 6 个月内与 SEMS 相关干预的总费用更低（6510 美元和 8100 美元，P = 0.004）。初次 ERCP 时胰腺和胆道癌症的病理诊断率分别为 52%和 61%。初次 ERCP 诊断失败后，重复 ERCP 时的胰腺癌症病理诊断率为 32%，而 EUS 引导下细针抽吸（FNA）时为 76%（P = 0.005）。
尽管具有潜在的成本效益，但一步法 SEMS 与支架迁移增加相关。与 EUS 引导下 FNA 相比，重复 ERCP 的病理诊断额外收益较低。
