胰管内外引流对胰十二指肠切除术后胰瘘影响的前瞻性比较研究

Prospective comparison between the effects of internal and external pancreatic duct drainage on pancreatic fistula after pancreaticoduodenectomy

目的 比较分析内部和外部两种引流方法对胰十二指肠切除术后胰瘘和其他并发症的影响。方法 前瞻性收集从2011年12月至2016年8月在天津医科大学肿瘤医院接受胰十二指肠切除术的119例病人,将病人随机分为内引流组(61例)和外引流组(58例)。比较分析两组病人术后住院信息。主要研究终点是胰瘘发生率,次要研究终点包括术后并发症发生率、院内死亡率和术后住院时间。结果 在内引流组,胰腺质地人柔软的病人比例高于外引流组(68.9%vs.48.3%,P=0.026)。内引流组中,有35例(57.4%)发生胰瘘,其中9例(14.7%)按国际胰瘘研究小组(ISGPF)标准分级为B级和C级胰瘘。而外引流组中,有29例(50.0%)病人发生胰瘘,其中有5例(8.6%)按ISGPF标准分级为B级和C级胰瘘。内外引流组之间的术后胰瘘发生率差异无统计学意义(57.4%vs.50.0%,χ^(2)=0.651,P=0.420)。在两组中,胃排空延迟、腹部感染、出血、胆漏以及术后住院时间的发生率差异亦无统计学意义(P均> 0.05)。其中,内引流组有1例病人死于术后腹部感染,外引流组有1例病人在术后第4天死于腹腔出血。单因素分析结果显示,胰腺质地柔软与术后胰瘘有关(P<0.001)。多因素分析结果显示,胰腺质地是术后胰瘘的独立危险因素(OR=0.422,95%CI 0.200-0.892,P=0.024)。结论 在胰十二指肠切除术中使用胰管支架进行内部引流是一种安全、可靠、简便的胰管引流方式,其相较于外引流,即使在胰管非扩张、胰腺质地柔软等高危因素的病人中,也并未表现出更高的术后胰瘘发生率。

Objective Pancreatic fistula is the primary cause of severe complications after pancreatoduodenectomy.This prospective randomized trial compared internal drainage with external drainage in pancreatoduodenectomy to observe the effect of two drainage methods on postoperative pancreatic fistula(PF) and other complications.Methods Between December 2011 and August 2016,a prospective randomized trial(NCT01634971 registered at http://Clinical Trials.gov) with patients who underwent pancreaticoduodenectomy was conducted.A total of 119 patients were randomly divided into an internal drainage group(61 cases) and an external drainage group(58 cases).The postoperative courses between the two groups were compared.The primary endpoint was pancreatic fistula rate,while secondary endpoints included the occurrence rate of postoperative complications,in-hospital mortality,and length of postoperative hospital stay.Results abdominal hemorrhage on the fourth day.Univariate analysis showed that a soft pancreas was associated with postoperative pancreatic fistula(P>0.001).Multivariate analysis showed that pancreatic texture was an independent risk factor for postoperative pancreatic fistula(OR=0.422,95% CI 0.200-0.892,P=0.024).Conclusion Internal drainage using a pancreatic duct stent in pancreaticojejunostomy is a safe,reliable and simple way of pancreatic duct drainage,and it has not demonstrated a higher probability of postoperative pancreatic fistula compared with external drainage,even in patients with high-risk factors such as a nondilated pancreatic duct and soft pancreatic texture.