Real Life Hybrid Ivor-Lewis Esophagectomy: Challenging the Randomized Controlled Trials Endpoints

Abstract Background Since the publication of the first randomized controlled trials (RCTs), minimally invasive esophagectomy (MIE) has been implemented worldwide. The aim of this study is to compare the results of a tertiary high-volume center for esophageal cancer with the endpoints of the available randomized controlled trials. Methods This is a retrospective monocentric analysis on a prospectively collected database. Patients undergoing hybrid Ivor-Lewis esophagectomy between August 2017 and October 2024 were included into the analysis.The primary endpoint was the comparison between the primary endpoint results of the RCTs and those of our patient cohort. The secondary endpoint was the analysis of postoperative and pathological outcomes. Numbers and percentages were used for reporting categorical variables and the χ2 test was used for comparisons. Continuous data were expressed as the median and interquartile range (IQR 25%–75%) and Kruskal-Wallis test was used for comparisons. Results 314 patients were included into the analysis. Most patients had distal esophageal (136,44.2%) or junctional (180,58.4%) cancer. Preoperative treatment was completed in 93.8% of patients. Sixty-one (20.5%) patients were admitted to postoperative ICU. R0 resection has been achieved in 97.7% of patients, median number of harvested lymph nodes was 35 (IQR 27–44). Postoperative complications occurred in 50.2% of the patients, with major complications (CD = IIIa) in 11.5%. Anastomotic type I leak was observed in 4 patients (1.3%). Pneumonia and pleural effusion occurred in 12 patients (3.9%). The median hospital stay was 11 days, and 90-days mortality rate was 0.3%. Conclusion Data coming from the RCTs must be cautiously interpreted before embarking on minimally invasive esophagectomy, especially in non-high-volume centers. Adding the anastomotic leak among the primary endpoints could lead to better evidence of future trials.