食管活瓣成形-胃食管套接术预防食管癌术后吻合口并发症的效果分析

Esophageal valve forming esophageal and gastric sleeve joint surgery for preventing postoperative anastomotic complications of esophageal cancer

目的明确食管活瓣成形-胃食管套接术预防食管癌术后吻合口并发症的效果。方法预先设计了一项随机对照试验,纳入2010年1月至2013年6月共394例食管癌患者。该项研究已在中国临床试验中心注册,并获得了注册号:ChiCTRTRC-13003817。有9例(2.3%)患者因未行食管癌根治术被排除,余下的所有患者均遵循随机分组的原则,随机分为两组,A组191例,B组194例。A组为试验组,术中接受食管活瓣成形-胃食管套接吻合,而B组为对照组,术中接受常规器械吻合。比较两组术后并发症发生情况。结果术后吻合口瘘的发生率在A组和B组分别为4.1%和3.6%,差异无统计学意义(P=0.768)。在观察术后吻合口狭窄时有7例患者因术后死亡而失访。在剩下的病例中,观察到A组和B组术后吻合口狭窄发生例数分别为13例(6.9%)和25例(13.2%),差异有统计学意义(P=0.044)。此外对于术后胃食管返流的监测发现,A组和B组术后返流性食管炎和Barrett食管的例数分别为54例(28.7%)和105例(55.3%),差异有统计学意义(P<0.01)。结论食管活瓣成形-胃食管套接术能有效预防术后胃食管返流的发生,同时也能降低术后吻合口狭窄的发生率。

Objective To clarify the effect of esophageal valve forming esophageal and gastric sleeve joint surgery for preven‐ting postoperative anastomotic complications of esophageal cancer .Methods A randomized controlled trial was designed to incorpo‐rate a total of 394 patients with esophageal cancer from January 2010 to June 2013 .This study has been registered in the Chinese clinical trial center and received a registration number ：ChiCTR‐TRC‐13003817 .Among them ,9 cases （2 .3% ） were excluded be‐cause of the non line esophageal cancer radical operation .The remaining patients were randomly divided into two groups ,191 cases in group A and 194 cases in group B ,according to the principle of random grouping .Group A was experimental group ,patients ac‐cepted esophageal valve forming esophageal and gastric sleeve joint surgery ,and group B was the control group ,patients received conventional anastomosis .Results The incidence of anastomotic leakage after operation in group A and group B were 4 .1% and 3 .6% ,thse results were not statistically significant （P=0 .768） .In the observation of anastomotic stenosis ,7 patients died after sur‐gery .In the remaining cases ,there were 13 cases （6 .9% ） and 25 cases （13 .2% ） in group A and group B ,respectively ,the differ‐ence was statistically significant （P=0 .044） .Furthermore ,reflux oesophagitis and Barrett′s epithelium were found in 105 patients （55 .3% ） in group B ,and 54 （28 .7% ） patients in group A ,the difference was statistically significant （P〈0 .01） .Conclusion E‐sophageal valve forming esophageal and gastric sleeve joint surgery can effectively prevent postoperative gastroesophageal reflux , but also can reduce the postoperative incidence of anastomotic stenosis .