P175 TRANSLATION OF MINIMALLY INVASIVE ESOPHAGECTOMY FROM RANDOMIZED CONTROLLED TRIAL SETTING (TIME) TO NATIONAL PRACTICE (DUCA) IN NETHERLANDS

Abstract Aims The TIME trial showed reduced pulmonary complications from minimally invasive esophagectomy (MIE) over an open approach, and led to widespread adoption of MIE in the Netherlands. The aim of this study was to compare clinical outcomes from minimally invasive esophagectomy in the DUCA (national dataset) and the TIME trial (RCT) for transthoracic esophagectomy1. Methods Original patient data from the TIME trial1 was extracted along-with data from the Dutch National Cancer Audit (DUCA) (2011-2017). Initially univariate analysis was used to compare patient and tumor demographics and clinical and pathological outcomes from patients receiving MIE in the TIME trial and in the DUCA-dataset. Secondly multivariate analysis, with adjustment patient and tumor factors, was performed for the effect of MIE vs. Open esophagectomy on clinical outcomes in both datasets. Thirdly the datasets were combined and multivariate analysis, was performed for the effect of patient inclusion in TIME trial or DUCA-dataset. Results 115 patients from TIME (59 MIE vs. 56 open) and 4605 patients from the DUCA-dataset (2652 MIE vs. 1953 open) were included. Univariate analysis showed, in TIME trial, MIE reduced postoperative complications and length of hospital stay. However in the DUCA-dataset, MIE increased postoperative complications, re-intervention rate and length of hospital stay, however pathological benefits included increased proportion of R0 margin and lymph nodes harvested. Multivariate analysis confirmed the TIME data showed MIE reduced postoperative complications (OR=0.38, 95%CI 0.16–0.90). In the DUCA-dataset, MIE was associated with increased postoperative complications (OR=1.37, 95%CI 1.20–1.55), re-intervention (OR=1.84, 95%CI 1.57–2.14), and length of hospital stay (Coeff=1.57, 95%CI 0.06–3.08). Pathological benefits to MIE in the DUCA-dataset included a reduction in proportion of R1 margin, and increased lymph node harvest. Multivariate analysis of the combined dataset, showed inclusion in the TIME trial was associated with a reduction in postoperative complications (OR=0.23, 95%CI 0.15–0.36) and reoperation rate (OR=0.34, 95%CI 0.17–0.66). Conclusions MIE when adopted nationally outside the TIME-trial, was associated with an increase in postoperative complications and reoperation rate, which may reflect surgeons on a national level going through their proficiency-gain curve in the technique and outside of expert MIE centers.