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Top Line: When surgical techniques are developed and rigorously tested in a randomized trial, how well do they translate to real world practice?
The Study: Several trials have shown significant reduction in post-operative complications for minimally invasive esophagectomy (MIE). One of these was the Dutch TIME trial, which has led to increased utilization of MIE in routine practice. The Dutch Upper GI Cancer Audit (DUCA) was designed to externally validate the results of the TIME trial. Operations on TIME occurred between 2010 and 2012 and included 56 patients who received open surgery and 59 patients who received MIE. The DUCA dataset included operations between 2011 and 2017 with over 1900 open surgeries and over 2600 MIE. While MIE reduced pulmonary complications in the TIME trial, there was a significant increase in overall complications, pulmonary complications, re-operation rate, and length of hospitalization in the DUCA dataset. On the other hand, real-world MIE was associated with lower 30-day mortality and a higher rate of R0 resection. Comparison of the MIE patients from TIME and DUCA showed that the former had a much lower rate of complications and re-operation. More globally, this brings up some interesting questions about the general applicability of other technique-driven advances in cancer treatment and general need for phase 4 validation. For instance, are recently trained or remotely trained practitioners struggling more with new techniques?
TBL: The benefits of minimally invasive esophagectomy demonstrated in the Dutch TIME trial translated to worse complications when actually applied in Dutch surgical practice. | Markar, J Clin Oncol 2020