A Phase III Randomized Controlled Trial of Pyloroplasty versus No Pyloroplasty in Patients Undergoing Minimally Invasive Esophagectomy or Robot-Assisted Minimally Invasive Esophagectomy
Abstract
OBJECTIVE
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).
BACKGROUND
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.
METHODS
An adaptive randomization trial design was utilized to maximize patients treated on 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.
RESULTS
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) vs. no pyloroplasty (n=44). Pneumonia or an anastomotic leak occurred in 16 of 90 (18%) patients in the pyloroplasty arm vs. 12 of 44 (27%) in the no-pyloroplasty arm. The stopping criteria were met when the posterior probability of pyloroplasty being superior reached 90%.
CONCLUSIONS
The design of this trial led to early stopping because the short-term…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 143 participants or records.
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