Abstract
BackgroundCurrently, there are three main surgical approaches for resectable esophageal cancer: open transthoracic esophagectomy (OTE), conventional minimally invasive esophagectomy (MIE) and robot-assisted esophagectomy (RAE). Previous studies had demonstrated the better short-term outcomes in MIE or RAE when compared to OTE, respectively. However, to date, no prospective study was designed to compare these two minimally invasive approaches (MIE and RAE). The primary objective of this study is to compare the outcomes on survival, safety and efficacy, quality of life between RAE and MIE in the treatment for resectable esophageal squamous cell carcinoma (ESCC).MethodsThis study is designed as a multicenter, prospective, randomized, non-inferiority phase III clinical trial, investigating the safety and efficacy of RAE compared with MIE in the treatment of resectable ESCC. Eligible patients are randomly assigned to either RAE (n = 180) or MIE (n = 180) group. The follow-up visits will be scheduled at 3, 6, 9, and 12 months in the first two years, and then every 6 months until the end of the study. During the follow-up period, clinical data and quality of life questionnaires will be examined. The primary endpoint is the 5-year overall survival (OS). The secondary endpoints are 3-year OS, 5-year disease-free survival (DFS), short-term outcomes as well as quality of life.DiscussionThis is the first prospectively randomized controlled trial designed to compare RAE with MIE as surgical treatment for resectable ESCC. According to our hypothesis, RAE will result in at least similar oncologic outcomes and long-term quality of life, but with a shorter operation time, lower percentage of perioperative complications, lower blood loss, and shorter hospital stay when compared with MIE. This study started in July 2017. Follow-up will terminate after 5 years from the time when the last patient was enrolled.Trial registrationClinicalTrial.gov: NCT03094351 (March 29, 2017). The trial was prospectively registered.
Highlights
There are three main surgical approaches for resectable esophageal cancer: open transthoracic esophagectomy (OTE), conventional minimally invasive esophagectomy (MIE) and robot-assisted esophagectomy (RAE)
The results demonstrated that RAE resulted in a lower incidence of postoperative complications and better quality of life when compared to OTE
Minimally invasive esophagectomy, including MIE and RAE, have been used to reduce postoperative complication and improve postoperative recovery compared with open esophagectomy
Summary
Study design This is a prospectively randomized controlled trial to assess the comparison between RAE and MIE in the treatment for patients with ESCC. The present study was designed as a non-inferiority trial, which was based on the hypothesis that the 5-year overall survival in the RAE is uncompromised with MIE. 1) Cervical esophageal cancer and carcinoma of gastro-esophageal junction; 2) Patients with unresectable or metastatic esophageal cancer; 3) Histological subtype of esophageal non-squamous cell carcinoma; 4) History of previous thoracic surgery; 5) Patients with other malignant tumor (previous or current); 6) Participation in another clinical trial during this study. 4) Short-term outcomes: Short-term outcome refers to operation related index during the perioperative period, which includes operative time, total blood loss, R0 resection rate, total and positive numbers of dissected lymph nodes, 30- and 90-day postoperative mortality, length of hospital stay and ICU stay, postoperative recovery, and the incidence of treatment-related complications. It is still at the stage of recruiting as 210 patients have been recruited until December 1st, 2018
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