Department of General and Visceral Surgery, Freiburg, Germany.
Trials. 2012 Apr 27;13:45. doi: 10.1186/1745-6215-13-45.
Pancreatoduodenectomy is one of the most complex abdominal operations, usually performed for tumors of the periampullary region and chronic pancreatitis. Leakage of pancreatic juice from the pancreatoenteric anastomosis, called postoperative pancreatic fistula, is the most prominent postoperative complication. Retrospective studies show a significant reduction of fistula rates with pancreatogastrostomy as compared to pancreatojejunostomy, the most frequently employed method of pancreatoenterostomy. Most single-center prospective trials, however, have not validated this finding. A large multicenter trial is needed for clarification.
METHODS/DESIGN: RECOPANC is a prospective, randomized, controlled multicenter trial with two treatment arms, pancreatogastrostomy versus pancreatojejunostomy. The trial hypothesis is that postoperative pancreatic fistula rate is lower after pancreatogastrostomy when compared to pancreatojejunostomy. Fourteen academic centers for pancreatic surgery will participate to allocate 360 patients to the trial. The duration of the entire trial is four years including prearrangement and analyses.
Postoperative pancreatic fistula is the main reason for clinically important postoperative morbidity after pancreatoduodenectomy. The primary goal of the chosen reconstruction technique for pancreatoenteric anastomosis is to minimize postoperative fistula rate. A randomized trial performed at multiple high-volume centers for pancreatic surgery is the best opportunity to investigate one of the most crucial issues in pancreatic surgery.
German Clinical Trials Register DRKS00000767 (2011/03/23), FSI 2011/05/31. Universal Trial Number U1111-1117-9588.
胰十二指肠切除术是最复杂的腹部手术之一，通常用于治疗壶腹周围区域的肿瘤和慢性胰腺炎。胰肠吻合口的胰液渗漏，即术后胰瘘，是最突出的术后并发症。回顾性研究表明，与最常采用的胰肠吻合术（胰肠吻合术）相比，胰胃吻合术使瘘管发生率显著降低。然而，大多数单中心前瞻性试验并未证实这一发现。需要进行大型多中心试验以明确这一点。
方法/设计：RECOPANC 是一项前瞻性、随机、对照的多中心试验，有两个治疗组，胰胃吻合术与胰肠吻合术。试验假设是，与胰肠吻合术相比，胰胃吻合术后的术后胰瘘发生率更低。14 家胰腺外科学术中心将参与试验，将 360 例患者分配到两个治疗组中。整个试验的持续时间为四年，包括预先安排和分析。
术后胰瘘是胰十二指肠切除术后发生临床重要术后发病率的主要原因。选择的胰肠吻合重建技术的主要目标是尽量降低术后瘘管发生率。在多个胰腺外科大容量中心进行的随机试验是研究胰腺外科最关键问题之一的最佳机会。
德国临床试验注册处 DRKS00000767（2011 年 3 月 23 日），FSI 2011 年 5 月 31 日。通用试验编号 U1111-1117-9588。
