A randomized controlled trial exploring the effect of placement versus nonplacement of a drainage tube around the cervical anastomosis in McKeown esophagectomy

Abstract

Purpose Esophageal cancer has an overall five-year survival rate of < 20%. The McKeown esophagectomy is invasive and carries a high risk of anastomotic leakage. Robust prospective outcome data comparing non-placement versus placement of a cervical drainage tube during McKeown esophagectomy are lacking. This study aimed to evaluate whether the placement of a cervical drainage tube is useful. Methods In this randomized controlled, noninferiority trial, 106 patients with histologically proven, surgically resectable esophageal carcinoma were randomized to either placement or non-placement of a cervical drainage tube. The primary outcome was the percentage of Clavien–Dindo grade 2 or higher anastomotic leakage. Secondary outcomes included the duration from surgery to oral intake, hospital stay, and type and dose of analgesics used during hospitalization. Results Fifty-two and 54 patients were randomized to McKeown esophagectomy with non-placement and placement of a cervical drainage tube, respectively. There was no significant difference in anastomotic leakage rates between the drain placement. However, non-inferiority was not demonstrated (13/54 [24%]) and non-placement groups (12/52 [23%]; risk difference, -0.100 [-0.17, 0.15]; p = 0.0591). There were no significant differences in the secondary outcome measures. Conclusion Non-inferiority of nonplacement of a drainage tube around the cervical anastomosis after McKeown esophagectomy to placement of that was not demonstrated. Further large multicenter studies are needed. Trial registration : Japan Registry of Clinical Trials (identification number: jRCT1052180016).