A single blinded randomized controlled trial comparing semi‐mechanical with hand‐sewn cervical anastomosis after esophagectomy for cancer (SHARE‐study)

OBJECTIVE: The aim was to compare leak rate between hand‐sewn end‐to‐end anastomosis (ETE) and semi‐mechanical anastomosis (SMA) after esophagectomy with gastric tube reconstruction. BACKGROUND DATA: The optimal surgical technique for creation of an anastomosis in the neck after esophagectomy is unclear. METHODS: Patients with esophageal cancer undergoing esophagectomy with gastric tube reconstruction and cervical anastomosis were eligible for participation after written informed consent. Patients were randomized in 1:1 ratio. Primary endpoint was anastomotic leak rate defined as external drainage of saliva from the site of the anastomosis or intra‐thoracic manifestation of leak. Secondary endpoints included anastomotic stricture rate at one year follow up, number of endoscopic dilatations, dysphagia‐score, hospital stay, morbidity, and mortality. Patients were blinded for intervention. RESULTS: Between August 2011 and July 2014, 174 patients with esophageal cancer underwent esophagectomy. Ninety‐three patients were randomized to ETE (n = 44) or SMA (n = 49). Anastomotic leak occurred in 9 of 44 patients (20%) in the ETE group and 12 of 49 patients (24%) in the SMA group (absolute difference 4%, 95% CI −13% to +21%; p = .804). There was no significant difference in dysphagia at 1 year postoperatively (ETE 25% vs. SMA 20%; p = .628), in stricture rate (ETE 25% vs. 19% in SMA, p = .46), nor in median hospital stay (17 days in the ETE group, 13 days in the SMA group), morbidity (82% vs. 73%, p = .460) or mortality (0% vs. 4%, p = .175) between the groups.