Abstract
BackgroundEsophagectomy with extended lymphadenectomy remains the mainstay of treatment for localized esophageal cancer. Currently, transthoracic and abdominal esophagectomy with cervical anastomosis (McKeown esophagectomy) is a frequently used technique in Japan. However, cervical anastomosis is still an invasive procedure with a high incidence of anastomotic leakage. The use of a drainage tube to treat anastomotic leakage is effective, but the routine placement of a closed suction drain around the anastomosis at the end of the operation remains controversial. The objective of this study is to evaluate the postoperative anastomotic leakage rate, duration to oral intake, hospital stay, and analgesic use with nonplacement of a cervical drainage tube as an alternative to placement of a cervical drainage tube.MethodsThis is an investigator-initiated, investigator-driven, open-label, randomized controlled parallel-group, noninferiority trial. All adult patients (aged ≥20 and ≤85 years) with histologically proven, surgically resectable (cT1–3 N0–3 M0) squamous cell carcinoma, adenosquamous cell carcinoma, or basaloid squamous cell carcinoma of the intrathoracic esophagus, and European Clinical Oncology Group performance status 0, 1, or 2 are assessed for eligibility. Patients (n = 110) with resectable esophageal cancer who provide informed consent in the outpatient clinic are randomized to either nonplacement of a cervical drainage tube (n = 55) or placement of a cervical drainage tube (n = 55).The primary outcome is the percentage of Clavien–Dindo grade 2 or higher anastomotic leakage.DiscussionThis is the first randomized controlled trial comparing nonplacement versus placement of a cervical drainage tube during McKeown esophagectomy with regards to the usefulness of a drain for anastomotic leakage. If our hypothesis is correct, nonplacement of a cervical drainage tube will be recommended because it is associated with a similar anastomotic leakage rate but less pain than placement of a cervical drainage tube.Trial registrationUMIN-CTR, 000031244. Registered on 1 May 2018.
Highlights
Esophagectomy with extended lymphadenectomy remains the mainstay of treatment for localized esophageal cancer
We hypothesize that nonplacement of a cervical drainage tube leads to a noninferior postoperative anastomotic leakage rate, duration to oral intake, hospital stay, and less analgesic use compared with placement of a cervical drainage tube, which is the current standard of care
Whether to place a drain near the cervical anastomosis after McKeown esophagectomy remains controversial, even though drains usually are inserted near the cervical anastomosis at most institutions
Summary
Esophagectomy with extended lymphadenectomy remains the mainstay of treatment for localized esophageal cancer. The use of a drainage tube to treat anastomotic leakage is effective, but the routine placement of a closed suction drain around the anastomosis at the end of the operation remains controversial. The use of a drainage tube as treatment for anastomotic leakage is effective [9], but the efficacy of routinely placing a closed suction drain around the anastomosis at the end of the operation remains controversial. Choi et al reported a randomized trial to evaluate the role of a drainage tube for the esophageal cervical anastomosis in 40 patients They concluded that routine use of a neck drain for esophageal anastomosis in the neck is not necessary as there were no anastomotic leaks, seromas or hematomas in either group [10]. A cervical drainage tube might lead to respiratory complications including pneumothorax if it were placed from the neck into the thorax [11]
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