Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands.
N Engl J Med. 2010 Jan 14;362(2):129-37. doi: 10.1056/NEJMoa0903230.
The benefits of preoperative biliary drainage, which was introduced to improve the postoperative outcome in patients with obstructive jaundice caused by a tumor of the pancreatic head, are unclear.
In this multicenter, randomized trial, we compared preoperative biliary drainage with surgery alone for patients with cancer of the pancreatic head. Patients with obstructive jaundice and a bilirubin level of 40 to 250 micromol per liter (2.3 to 14.6 mg per deciliter) were randomly assigned to undergo either preoperative biliary drainage for 4 to 6 weeks, followed by surgery, or surgery alone within 1 week after diagnosis. Preoperative biliary drainage was attempted primarily with the placement of an endoprosthesis by means of endoscopic retrograde cholangiopancreatography. The primary outcome was the rate of serious complications within 120 days after randomization.
We enrolled 202 patients; 96 were assigned to undergo early surgery and 106 to undergo preoperative biliary drainage; 6 patients were excluded from the analysis. The rates of serious complications were 39% (37 patients) in the early-surgery group and 74% (75 patients) in the biliary-drainage group (relative risk in the early-surgery group, 0.54; 95% confidence interval [CI], 0.41 to 0.71; P<0.001). Preoperative biliary drainage was successful in 96 patients (94%) after one or more attempts, with complications in 47 patients (46%). Surgery-related complications occurred in 35 patients (37%) in the early-surgery group and in 48 patients (47%) in the biliary-drainage group (relative risk, 0.79; 95% CI, 0.57 to 1.11; P=0.14). Mortality and the length of hospital stay did not differ significantly between the two groups.
Routine preoperative biliary drainage in patients undergoing surgery for cancer of the pancreatic head increases the rate of complications. (Current Controlled Trials number, ISRCTN31939699.)
术前胆道引流术被引入以改善因胰头肿瘤引起的梗阻性黄疸患者的术后结果，但该手术的益处并不明确。
在这项多中心、随机试验中，我们比较了术前胆道引流术与单纯手术治疗胰头癌患者的效果。将伴有梗阻性黄疸且胆红素水平为 40 至 250μmol/L（2.3 至 14.6mg/dL）的患者随机分为两组，一组在诊断后 1 周内行单纯手术，另一组则先行术前胆道引流 4 至 6 周，然后手术。术前胆道引流术主要通过内镜逆行胰胆管造影术（ERCP）放置支架来进行。主要结局为随机分组后 120 天内严重并发症的发生率。
我们共纳入 202 例患者，其中 96 例患者被分至早期手术组，106 例患者被分至术前胆道引流组，另有 6 例患者被排除在分析之外。早期手术组严重并发症的发生率为 39%（37 例），而术前胆道引流组为 74%（75 例）（早期手术组的相对风险为 0.54；95%置信区间为 0.41 至 0.71；P<0.001）。在尝试 1 次或更多次后，96 例（94%）患者的术前胆道引流术成功，其中 47 例（46%）患者出现并发症。早期手术组中有 35 例（37%）患者发生手术相关并发症，而术前胆道引流组中有 48 例（47%）患者发生该并发症（相对风险为 0.79；95%置信区间为 0.57 至 1.11；P=0.14）。两组患者的死亡率和住院时间无显著差异。
在胰头癌手术患者中常规行术前胆道引流术会增加并发症发生率。（当前的临床试验注册编号，ISRCTN31939699。）
