RESULTS OF A JAPANESE MULTICENTER, RANDOMIZED TRIAL OF ENDOSCOPIC STENTING FOR NON-RESECTABLE PANCREATIC HEAD CANCER (JM-TEST): COVERED WALLSTENT VERSUS DOUBLELAYER STENT
RESULTS OF A JAPANESE MULTICENTER, RANDOMIZED TRIAL OF ENDOSCOPIC STENTING FOR NON-RESECTABLE PANCREATIC HEAD CANCER (JM-TEST): COVERED WALLSTENT VERSUS DOUBLELAYER STENT
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DOI：
10.1111/j.1443-1661.2011.01124.x
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发表时间：
2011-10-01
影响因子：
5.3
通讯作者：
Tamada, Kiichi
中科院分区：
文献类型：
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作者：
Isayama, Hiroyuki;Yasuda, Ichiro;Tamada, Kiichi
背景：没有研究比较覆盖金属支架和Tannenbaum支架。我们评估了双层支架（DLS）和覆盖支架（CWS）在胰头癌（PHC）患者中的疗效。患者和方法：这是一项多中心、前瞻性随机研究。在2005年10月至2007年12月期间，我们招募了113例伴有远端胆道阻塞的不可切除PHC患者（58例DLS， 55例CWS），并对其进行了至少6个月的观察。结果：两组患者的生存期无显著差异，DLS组和CWS组的中位生存期分别为231天和248天。CWS组支架累计通畅率显著高于对照组（P = 0.0072）。DLS组的平均和中位支架通畅度分别为202和133天，CWS组的平均和中位支架通畅度分别为285和419天。DLS咬合发生率（53.5%）显著高于CWS (23.6%), P = 0.0019。阻塞的原因分别是肿瘤过度生长（0,1）、向内生长（0,2）、淤积（24,2）、食物嵌塞（3,5）、胆管扭结（2,0）和其他（2,3）。其他并发症有胆囊炎（0,4）、胰腺炎（0,1）、迁移（1,5）、肝脓肿（2,0）和其他（1,2）。两组间并发症发生率无显著差异。结论：CWS治疗PHC合并梗阻性黄疸的通畅时间明显长于DLS。CWS患者除支架闭塞外的并发症发生率较高，但差异无显著性。
Background: No study has compared covered metallic stents with Tannenbaum stents. We evaluated the efficacy of the DoubleLayer stent (DLS) and Covered Wallstent (CWS) in patients with pancreatic head cancer (PHC).Patients & Methods: This was a multicenter, prospective randomized study. Between October 2005 and December 2007, we enrolled 113 patients (58 DLS, 55 CWS) with unresectable PHC with distal biliary obstructions and observed them for at least 6 months.Results: No significant difference in patient survival was found between groups, with a median survival of 231 and 248 days in the DLS and CWS groups, respectively. The cumulative stent patency was significantly higher (P = 0.0072) in the CWS group. The respective mean and median stent patency was 202 and 133 days in the DLS group and 285 and 419 days in the CWS group. The incidence of DLS occlusion (53.5%) was significantly higher than that of CWS (23.6%; P = 0.0019). The respective causes of occlusion were tumor overgrowth (0, 1), ingrowth (0, 2), sludge (24, 2), food impaction (3, 5), kinking bile duct (2, 0), and other (2, 3). Other complications were cholecystitis (0, 4), pancreatitis (0, 1), migration (1, 5), liver abscess (2, 0), and other (1, 2). No significant difference in the incidence of complications between groups was observed.Conclusion: CWS had significantly longer patency than DLS for the management of PHC with obstructive jaundice. The incidence of complications other than stent occlusion was higher in CWS, but this difference did not reach significance.