Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, Sapporo, Japan.
Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
Clin Gastroenterol Hepatol. 2015 Jun;13(6):1151-8.e2. doi: 10.1016/j.cgh.2015.01.008. Epub 2015 Jan 26.
BACKGROUND & AIMS: Endoscopic sphincterotomy (ES) is performed routinely before self-expandable metallic stents (SEMS) are placed in malignant distal biliary strictures to prevent postprocedural pancreatitis. However, it is not clear whether ES actually prevents pancreatitis or affects other adverse events (AEs). We conducted a noninferiority trial to examine the necessity of ES before SEMS placement.
Two hundred patients with distal biliary strictures caused by unresectable pancreatic cancer were assigned randomly to groups that received ES or did not receive ES (non-ES) before SEMS placement, at 25 hospitals in Hokkaido, Japan, from August 2010 through November 2012. The primary outcome was early AEs (≤30 d) specifically related to the presence or absence of ES (pancreatitis, bleeding, or perforation). Secondary outcomes measured included the effect of ES omission on time to SEMS dysfunction and patient survival times.
The proportions of patients with early AEs were 9.2% in the non-ES group and 10.4% in the ES group (a difference of 1.2%, noninferior). The median times to SEMS dysfunction was longer than 594 days in the non-ES group and 541 days in the ES group (P = .88). The median overall survival times were 202 in the ES group vs 255 days in the non-ES group; P = .20).
ES before SEMS does not affect the incidence of AEs, SEMS patency, or patient survival times. Our data provide no evidence for a benefit of ES to patients undergoing SEMS placement for a biliary stricture caused by pancreatic cancer. UMIN clinical trials registry number: 000004044.
在放置自膨式金属支架（SEMS）之前，常规进行内镜下括约肌切开术（ES）以预防术后胰腺炎。然而，ES 是否能真正预防胰腺炎或影响其他不良事件（AEs）尚不清楚。我们进行了一项非劣效性试验，以检查在 SEMS 放置之前进行 ES 的必要性。
2010 年 8 月至 2012 年 11 月，在日本北海道的 25 家医院，将 200 例由不可切除胰腺癌引起的远端胆管狭窄患者随机分配到接受 ES 或不接受 ES（非 ES）的组，在 SEMS 放置之前。主要结局是与 ES 的有无特别相关的早期 AEs（≤30 d）（胰腺炎、出血或穿孔）。测量的次要结局包括 ES 遗漏对 SEMS 功能障碍和患者生存时间的影响。
非 ES 组的早期 AEs 发生率为 9.2%，ES 组为 10.4%（差异为 1.2%，非劣效）。非 ES 组 SEMS 功能障碍的中位时间长于 594 天，ES 组为 541 天（P =.88）。ES 组的总生存时间中位数为 202 天，非 ES 组为 255 天；P =.20）。
SEMS 前进行 ES 不会影响 AEs 的发生率、SEMS 通畅率或患者生存时间。我们的数据没有提供证据表明 ES 对接受 SEMS 治疗因胰腺癌引起的胆管狭窄的患者有益。UMIN 临床试验注册编号：000004044。
