Lancet Oncol：胰十二指肠切除术后行胰管胃吻合术可降低胰瘘发生率

在进行胰十二指肠切除术后所发生的胰瘘是造成术后死亡和发病的首要原因。然而，目前采用何种手术重建方法来降低胰瘘的发生——还存在着争议。来自比利时KU Leuven大学医院的Baki Topal等设计了一个多中心、随机对照优效性研究来比较在因胰腺肿瘤或壶腹周围肿瘤而接受胰十二指肠切除术的患者中，进行不同重建术对患者临床结局的影响。他们的研究结果发表在Lancet Oncol 5月的在线期刊上。

本研究所纳入的受试者为年龄在18岁至85岁期间、确诊为或怀疑为胰腺、远端胆管、壶腹部、十二指肠或壶腹周围新生物的患者。研究者采用网络平台随机将符合上述入组标准的受试者分为2组，在接受完胰十二指肠切除术后——一组受试者接受胰管空肠吻合术，另一组则接受胰管胃吻合术。研究者根据受试者在进行手术时所测量的胰管直径将受试者进行分层（≤3 mm/>3 mm）。本研究的主要终点事件是在术后B级或C级胰瘘的发生情况（采用国际胰瘘研究小组所制定的标准进行评估）。本研究不设置盲法，研究者采用意向治疗分析法对研究结果进行分析。在受试者出院2个月后研究者即停止对受试者的随访。本研究在ClinicalTrials.gov注册，注册号为NCT00830778。

在2009年6月至2012年8月期间，有167名受试者进行了胰管空肠吻合术，另有162名受试者接受了胰管胃吻合术。在胰管空肠吻合术组中，有33名受试者（19.8%）在术后发生了胰瘘，而在胰管胃吻合术组中则有13名受试者（8.0%）在术后发生了胰瘘，OR为2.86，两组差异具有显著统计学意义。术后并发症的总体发生率在两组间并无显著差异，在胰管空肠吻合术组中为99，而在胰管胃吻合术组为100，但是与胰管胃吻合术组的受试者相比，胰管空肠吻合术组受试者的并发症多为3a以上级别的。

本研究结果指出，在由于胰头肿瘤或壶腹部肿瘤而接受了胰十二指肠切除术的患者中，在降低术后胰瘘发生率方面，与胰管空肠吻合术相比，胰管胃吻合术更有效。

Pancreaticojejunostomy versus pancreaticogastrostomy reconstruction after pancreaticoduodenectomy for pancreatic or periampullary tumours: a multicentre randomised trial
Background
Postoperative pancreatic fistula is the leading cause of death and morbidity after pancreaticoduodenectomy. However, the best reconstruction method to reduce occurrence of fistula is debated. We did a multicentre, randomised superiority trial to compare the outcomes of different reconstructive techniques in patients undergoing pancreaticoduodenectomy for pancreatic or periampullary tumours.
Methods
Patients aged 18—85 years with confirmed or suspected neoplasms of the pancreas, distal bile duct, ampulla vateri, duodenum, or periampullary tumours were eligible for inclusion. An internet-based platform was used to randomly assign patients to either pancreaticojejunostomy or pancreaticogastrostomy as reconstruction after pancreaticoduodenectomy, using permuted blocks with six patients per block. Within each centre the randomisation was stratified on the pancreatic duct diameter (≤3 mm vs >3 mm) measured at the time of surgery. The primary endpoint was the occurrence of clinical postoperative pancreatic fistula (grade B or C) as defined by the International Study Group on Pancreatic Fistula. The study was not masked and analyses were done by intention to treat. Patient follow-up was closed 2 months after discharge from the hospital. This study is registered with ClinicalTrials.gov, number NCT00830778.
Findings
Between June, 2009, and August, 2012, we randomly allocated 167 patients to receive pancreaticojejunostomy and 162 to receive pancreaticogastrostomy. 33 (19·8%) patients in the pancreaticojejunostomy group and 13 (8·0%) in the pancreaticogastrostomy group had clinical postoperative pancreatic fistula (OR 2·86, 95% CI 1·38—6·17; p=0·002). The overall incidence of postoperative complications did not differ significantly between the groups (99 in the pancreaticojejunostomy group vs 100 in the pancreaticogastrostomy group), although more events in the pancreaticojejunostomy group were of grade ≥3a than in the pancreaticogastrostomy group (39 vs 35).
Interpretation
In patients undergoing pancreaticoduodenectomy for pancreatic head or periampullary tumours, pancreaticogastrostomy is more efficient than pancreaticojejunostomy in reducing the incidence of postoperative pancreatic fistula.