A Phase III Randomized Controlled Trial of Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Minimally Invasive Esophagectomy or Robot-assisted Minimally Invasive Esophagectomy.

Abstract

To assess the value of adding of a pyloroplasty procedure during the performance of minimally invasive esophagectomy (MIE) or robotically assisted MIE (RAMIE), we conducted a prospective, phase III randomized controlled trial (RCT)(NCT03740542). Many surgeons include pyloroplasty when performing esophagectomy, but few studies have provided level 1 evidence to support or refute this step, especially in the era of MIE and RAMIE. An adaptive randomization trial design was utilized to maximize patients treated with a more effective therapy and conversely minimize accrual to a less effective procedure. The trial was designed to proceed until one arm was established as superior or until a total of 140 patients had been treated and deemed evaluable for response. The primary endpoints of the study were pneumonia and/or anastomotic leak requiring surgery within 30 days of surgery. Over a 4-year period, 143 patients were randomized, and 134 patients were evaluable. The greater likelihood of success for pyloroplasty throughout the trial resulted in more patients randomized towards pyloroplasty (n= 90) versus no pyloroplasty (n=44). Pneumonia or an anastomotic leak occurred in 16 of 90 (18%) patients in the pyloroplasty arm versus 12 of 44 (27%) in the no-pyloroplasty arm. The stopping criteria were met when the posterior probability of pyloroplasty being superior reached 90%. The design of this trial led to early stopping because the short-term results indicated that outcomes in the pyloroplasty arm were superior to the no-pyloroplasty arm. This RCT provides evidence for short-term benefits of adding pyloroplasty to MIE or RAMIE. The long-term outcomes and quality of life measures continue to be monitored.