Randomized clinical trial of external stent drainage of the pancreatic duct to reduce postoperative pancreatic fistula after pancreaticojejunostomy
Randomized clinical trial of external stent drainage of the pancreatic duct to reduce postoperative pancreatic fistula after pancreaticojejunostomy
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DOI：
10.1002/bjs.8654
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发表时间：
2012-04-01
影响因子：
9.6
通讯作者：
Unno, M.
中科院分区：
文献类型：
--
作者：
Motoi, F.;Egawa, S.;Unno, M.
背景：术后胰瘘（POPF）仍然是胰腺切除术（PD）后最常见的发病原因之一。本随机试验研究了胰管外支架引流是否降低PD和随后的胰肠吻合术（PJ）后POPF的发生率。方法：将接受PD和随后构建胰管粘膜PJ的患者随机分为支架组和非支架组。主要结局是临床相关POPF的发生率。次要结果是发病率和死亡率，和住院stay.Results：114 PD程序，93是适合纳入研究后，知情同意。支架组中临床相关POPF的发生率显著低于非支架组：47例患者中有3例（6%），而46例患者中有10例（22%）（P = 0.040）。在导管扩张的患者中，两组的POPF发生率相似。在未扩张导管的患者中，支架组的临床相关POPF明显低于非支架组：21例中的2例（10%）与20例中的8例（40%）（P = 0.033）。未观察到发病率或死亡率的显著差异。单变量分析确定体重指数（BMI）、胰腺癌、胰腺质地、胰管大小和胰管支架植入术是与临床相关POPF相关的风险因素。多变量分析，考虑到这五个因素确定高BMI（风险比（RR）11.45; P = 0.008），非扩张导管（RR 5.33; P = 0.046）和无支架（RR 10.38; P = 0.004）作为显着的风险factors.Conclusion：外导管支架植入术降低了临床相关的POPF后PD和随后的导管-粘膜PJ的风险。登记号：UMIN 000000952（http：//www.umin.ac.jp/ctr/index-j.htm）。
Background: Postoperative pancreatic fistula (POPF) remains one of the most common causes of morbidity following pancreaticoduodenectomy (PD). This randomized trial examined whether external stent drainage of the pancreatic duct decreases the rate of POPF after PD and subsequent pancreaticojejunostomy (PJ).Methods: Consecutive patients who underwent PD with subsequent construction of a duct-to-mucosa PJ were randomized into a stented and a non-stented group. The primary outcome was the incidence of clinically relevant POPF. Secondary outcomes were morbidity and mortality rates, and hospital stay.Results: Of 114 PD procedures, 93 were suitable for inclusion in the study after informed consent. The rate of clinically relevant POPF was significantly lower in the stented group than in the non-stented group: three of 47 (6 per cent) versus ten of 46 (22 per cent) (P = 0.040). Among patients with a dilated duct, rates of POPF were similar in both groups. Among patients with a non-dilated duct, clinically relevant POPF was significantly less common in the stented group than in the non-stented group: two of 21 (10 per cent) versus eight of 20 (40 per cent) (P = 0.033). No significant differences in morbidity or mortality were observed. Univariable analysis identified body mass index (BMI), pancreatic cancer, pancreatic texture, pancreatic duct size and duct stenting as risk factors related to clinically relevant POPF. Multivariable analysis taking these five factors into account identified high BMI (risk ratio (RR) 11.45; P = 0.008), non-dilated duct (RR 5.33; P = 0.046) and no stent (RR 10.38; P = 0.004) as significant risk factors.Conclusion: External duct stenting reduced the risk of clinically relevant POPF after PD and subsequent duct-to-mucosa PJ. Registration number: UMIN000000952 (http://www.umin.ac.jp/ctr/index-j.htm).