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

被引：0

作者：

Taro Oshikiri ^{[1
]}

Hironobu Goto ^{[1
]}

Takashi Kato ^{[1
]}

Gosuke Takiguchi ^{[1
]}

Yasufumi Koterazawa ^{[1
]}

Hiroshi Hasegawa ^{[1
]}

Shingo Kanaji ^{[1
]}

Kimihiro Yamashita ^{[1
]}

Takeru Matsuda ^{[2
]}

Tetsu Nakamura ^{[1
]}

Sae Murakami ^{[3
]}

Yoshihiro Kakeji ^{[1
]}

机构：

[1] Kobe University,Division of Gastrointestinal Surgery, Department of Surgery, Graduate School of Medicine

[2] Kobe University,Division of Minimally Invasive Surgery, Department of Surgery, Graduate School of Medicine

[3] Kobe University Hospital,Clinical and Translational Research Center

来源：

Scientific Reports | / 15卷 / 1期

关键词：

Anastomotic leak; Randomized controlled trial; Esophageal neoplasms; Drainage; Esophagectomy;

D O I：

10.1038/s41598-024-82623-0

中图分类号：

学科分类号：

摘要：

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.

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