Pancreaticojejunostomy versus pancreaticogastrostomy reconstruction after pancreaticoduodenectomy for pancreatic or periampullary tumours: a multicentre randomised trial
Pancreaticojejunostomy versus pancreaticogastrostomy reconstruction after pancreaticoduodenectomy for pancreatic or periampullary tumours: a multicentre randomised trial
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DOI：
10.1016/s1470-2045(13)70126-8
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发表时间：
2013-06-01
期刊：
影响因子：
51.1
通讯作者：
Closset, Jean
中科院分区：
文献类型：
--
作者：
Topal, Baki;Fieuws, Steffen;Closset, Jean
背景术后胰瘘是导致胰腺十二指肠切除术后死亡和并发症的主要原因。然而，减少瘘管发生的最佳重建方法仍存在争议。我们进行了一项多中心随机优势试验，以比较不同重建技术在胰腺或壶腹周围肿瘤切除患者中的效果。方法18-85岁确诊或疑似胰腺肿瘤、远端胆管、壶腹、十二指肠或壶腹周围肿瘤的患者符合纳入条件。使用基于互联网的平台将患者随机分配到胰腺空肠吻合术或胰胃吻合术，作为胰腺十二指肠切除术后的重建，使用置换块，每块6名患者。在每个中心内，根据手术时测量的胰管直径(3 Mm)分层进行随机分组。根据国际胰瘘研究小组的定义，主要终点是临床术后胰瘘(B级或C级)的发生。这项研究没有被掩盖，分析是通过意向治疗进行的。患者出院后2个月结束随访。这项研究在ClinicalTrials.gov上注册，编号NCT00830778。在2009年6月至2012年8月期间，我们随机分配167名患者接受胰管空肠吻合术，162名患者接受胰胃吻合术。胰腺空肠吻合组33例(19.8%)和胰胃吻合组13例(8.0%)术后发生胰瘘(OR2.86，95%CI1.38~6.17；P=0.002)。两组间术后并发症的总体发生率无显著差异(胰空肠组为99例，胰胃吻合组为100例)，但胰肠吻合组的3a级事件多于胰胃吻合组(39例对35例)。在因胰头或壶腹周围肿瘤而行胰十二指肠切除术的患者中，胰胃吻合术在降低术后胰瘘发生率方面比胰空肠吻合术更有效。
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) 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.