Second Department of Surgery, Wakayama Medical University, Jap.
Department of Surgery, Seoul National University, Republic of Korea.
Pancreatology. 2020 Jul;20(5):984-991. doi: 10.1016/j.pan.2020.06.014. Epub 2020 Jul 3.
Several studies comparing internal and external stents have been conducted with the aim of reducing pancreatic fistula after PD. There is still no consensus, however, on the appropriate use of pancreatic stents for prevention of pancreatic fistula. This multicenter large cohort study aims to evaluate whether internal or external pancreatic stents are more effective in reduction of clinically relevant pancreatic fistula after pancreaticoduodenectomy (PD).
We reviewed 3149 patients (internal stent n = 1,311, external stent n = 1838) who underwent PD at 20 institutions in Japan and Korea between 2007 and 2013. Propensity score matched analysis was used to minimize bias from nonrandomized treatment assignment. The primary endpoint was the incidence of clinically relevant pancreatic fistula. This study was registered on the UMIN Clinical Trials Registry (UMIN000032402).
After propensity score matched analysis, clinically relevant pancreatic fistula occurred in more patients in the external stents group (280 patients, 28.7%) than in patients in the internal stents group (126 patients, 12.9%) (OR 2.713 [95% CI, 2.139-3.455]; P < 0.001). In subset analysis of a high-risk group with soft pancreas and no dilatation of the pancreatic duct, clinically relevant pancreatic fistula occurred in 90 patients (18.8%) in internal stents group and 183 patients (35.4%) in external stents group. External stents were significantly associated with increased risk for clinically relevant pancreatic fistula (OR 2.366 [95% CI, 1.753-3.209]; P < 0.001).
Propensity score matched analysis showed that, regarding clinically relevant pancreatic fistula after PD, internal stents are safer than external stents for pancreaticojejunostomy.
已有多项研究比较了内支架和外支架,旨在降低 PD 后胰瘘的发生率。然而,对于预防胰瘘是否使用胰腺支架仍无共识。本多中心大样本研究旨在评估胰十二指肠切除术后(PD)内支架和外支架在减少临床相关胰瘘方面的效果。
我们回顾了 2007 年至 2013 年间在日本和韩国的 20 家机构接受 PD 的 3149 例患者(内支架组 n=1311 例,外支架组 n=1838 例)。采用倾向评分匹配分析来尽量减少非随机治疗分组造成的偏倚。主要终点是临床相关胰瘘的发生率。本研究已在 UMIN 临床试验注册中心(UMIN000032402)注册。
经倾向评分匹配分析,外支架组(280 例,28.7%)临床相关胰瘘的发生率高于内支架组(126 例,12.9%)(OR 2.713 [95%CI,2.139-3.455];P<0.001)。在胰腺质地软且胰管无扩张的高危人群亚组分析中,内支架组有 90 例(18.8%)和外支架组有 183 例(35.4%)发生临床相关胰瘘。外支架与临床相关胰瘘的风险增加显著相关(OR 2.366 [95%CI,1.753-3.209];P<0.001)。
倾向评分匹配分析表明,对于 PD 后临床相关胰瘘,胰肠吻合时内支架比外支架更安全。