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

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. 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. 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 non-placement (12/52 [23%]) and placement (13/54 [24%]) of drainage tube. However, non-inferiority was not demonstrated (risk difference, -0.100 [-0.17, 0.15]; p = 0.0591). There were no significant differences in the secondary outcome measures. 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).