Journal Article

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

Kanaji, Shingo, Nakamura, Tetsu, Hasegawa, Hiroshi, Oshikiri, Taro, Takiguchi, Gosuke, Yamashita, Kimihiro, Goto, Hironobu, Kakeji, Yoshihiro, Kato, Takashi, Koterazawa, Yasufumi, Murakami, Sae, Matsuda, Takeru

2025

Overview

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).

• Publisher: Nature Publishing Group,Nature Publishing Group UK,Nature Portfolio
• Subject: Aged / Analgesics / Anastomosis / Anastomosis, Surgical - adverse effects / Anastomosis, Surgical - methods / Anastomotic leak / Anastomotic Leak - etiology / Anastomotic Leak - prevention & control / Cancer / Clinical trials / Drainage / Drainage - instrumentation / Drainage - methods / Esophageal carcinoma / Esophageal neoplasms / Esophageal Neoplasms - surgery / Esophagectomy / Esophagectomy - adverse effects / Esophagectomy - methods / Esophagus / Female / Humans / Male / Middle Aged / Patients / Prospective Studies / Randomized controlled trial / Surgical anastomosis / Surgical drains / Treatment Outcome / Wound drainage