• Toshiaki Tsuji, Toshiyasu Ojima, Mikihito Nakamori, Masaki Nakamura, Masahiro Katsuda, Keiji Hayata, Junya Kitadani, Shimpei Maruoka, Toshio Shimokawa, and Hiroki Yamaue.
• Second Department of Surgery, School of Medicine, Wakayama Medical University, 811-1, Kimiidera, Wakayama, 641-8510, Japan.
• Trials. 2019 Jan 28; 20 (1): 83.

BackgroundSeveral 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.MethodsThis 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.DiscussionThis 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.Trial RegistrationUniversity Hospital Medical Information Network Clinical Trial Registry ( UMIN 000025632 ). Registered on 13 January 2017.

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