Triangulating stapling vs functional end-to-end stapling for cervical esophagogastric anastomosis after esophagectomy for thoracic esophageal cancer: study protocol for a randomized controlled trial
Triangulating stapling vs functional end-to-end stapling for cervical esophagogastric anastomosis after esophagectomy for thoracic esophageal cancer: study protocol for a randomized controlled trial
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DOI：
10.1186/s13063-019-3201-2
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发表时间：
2019-01-28
期刊：
影响因子：
2.5
通讯作者：
Yamaue, Hiroki
中科院分区：
文献类型：
--
作者：
Tsuji, Toshiaki;Ojima, Toshiyasu;Yamaue, Hiroki
背景：已有研究报道三角化吻合器可降低食管切除术后吻合口狭窄的发生率。然而，我们之前的随机对照试验并不能证实三角吻合器（TS）在术后吻合口狭窄率方面优于圆形吻合器（CS）。最近，功能性端到端吻合器（FEES）用于食管切除术后的颈部吻合，与我们之前经验的吻合方法相比，已经报道了较低的吻合口狭窄率。为了探讨最佳的吻合方式，我们比较了TS法和FEES法在胸段食管癌食管切除术后吻合口狭窄的减少情况。方法：这是一项随机、单中心临床试验，旨在检验FEES方法相对于TS方法对食管癌患者的优越性。主要终点是食管切除术后12个月内颈部食管胃吻合口狭窄减少。次要终点包括食管切除术后12个月内的总体术后发病率，吻合口漏、吸入性肺炎或反流性食管炎的发生率，以及食管切除术后12个月FACT-E测量的生活质量评估。TS法吻合口狭窄发生率为20%，而FEES法吻合口狭窄发生率在我们初步研究中估计为4%。我们计算样本量的beta误差为0.20，alpha误差为0.05。自2017年1月以来，我们已经在这项试验中招募了125名患者，分为TS组或FEES组。讨论：本研究有助于确定食管癌患者食管切除术后颈部食管胃吻合术的最佳吻合方式。如果证明FEES方法优于TS方法，则可常规应用于食管癌食管切除术后胃导管重建患者。
Background: Several studies have reported that the triangulating stapling method decreases the incidence of anastomotic stricture after esophagectomy. Our previous randomized controlled trial, however, could not confirm the superiority of the triangulating stapling (TS) method over the circular stapling (CS) method in terms of postoperative anastomotic stricture rate. Recently, the functional end-to-end stapling (FEES) method for cervical anastomosis after esophagectomy was developed, and lower anastomotic stricture rates with FEES have been reported than for our previously experienced anastomotic methods. To investigate the optimal anastomotic method, we now compare the TS method with the FEES method for cervical anastomosis regarding decrease in anastomotic stricture after esophagectomy for thoracic esophageal cancer.Methods: This is a randomized, single-center clinical trial designed to examine the superiority of the FEES method over the TS method for esophageal cancer patients. The primary endpoint is reduction of anastomotic stricture of cervical esophagogastric anastomosis within 12 months after esophagectomy. Secondary endpoints include overall postoperative morbidity within the first 12 months after esophagectomy, incidence of anastomotic leakage, aspiration pneumonia, or reflux esophagitis, and quality of life assessment as measured by the FACT-E at 12 months after esophagectomy. The incidence rate of anastomotic stricture of the TS method was 20% and this rate of the FEES method was estimated to be 4% in our preliminary study. We calculated sample size with a beta error of 0.20 and an alpha error of 0.05. We have been enrolling 125 patients in this trial to either the TS group or the FEES group since January 2017.Discussion: This study should help to define the optimal anastomotic method for cervical esophagogastric anastomosis after esophagectomy in patients with esophageal cancer. The FEES method, if proven to be superior to the TS method, can be implemented routinely for esophageal cancer patients with gastric-conduit reconstruction after esophagectomy.