Pyloroplasty During Esophagectomy Reduces Early Major Postoperative Complications, Improves Gastric Emptying

Luketich J, Sarkaria I, Levy R, et al. A Phase III Randomized Controlled Trial of Pyloroplasty versus No Pyloroplasty in Patients Undergoing Minimally Invasive Esophagectomy or Robot-Assisted Minimally Invasive Esophagectomy. Ann Surg. December 2025.

This phase III randomized controlled trial evaluated the clinical impact of adding pyloroplasty during minimally invasive esophagectomy (MIE) or robot-assisted MIE (RAMIE) using a Bayesian adaptive design. 

Over a 4-year period, 143 patients were randomized, with 134 evaluable for the primary analysis. The adaptive design preferentially allocated patients toward the superior arm, resulting in 90 patients undergoing pyloroplasty and 44 patients undergoing no pyloric drainage. The primary composite endpoint was the occurrence of pneumonia or an anastomotic leak requiring reoperation within 30 days. Baseline characteristics were well balanced between groups: median age was 66 years, 87% were male, 93% had malignant disease (predominantly adenocarcinoma), and 74% received neoadjuvant therapy. Most procedures were Ivor Lewis esophagectomies (87%), performed almost entirely with minimally invasive or robotic techniques.

The trial met its predefined stopping criteria when the probability of pyloroplasty superiority reached 90%. The composite primary endpoint occurred in 16 of 90 patients (17.6%–18%) in the pyloroplasty arm versus 12 of 44 patients (27.1%–27%) in the no-pyloroplasty arm, representing an approximate 35% relative reduction in major early postoperative complications (pneumonia and anastomotic leak). 

Importantly, gastric emptying was significantly improved in the pyloroplasty group, and pyloroplasty was independently associated with better postoperative emptying despite standardized construction of a tubular gastric conduit with no differences in conduit diameter or pylorus-to-staple-line distance between groups. There were no significant differences in 30-day mortality, length of stay, or nasogastric tube duration.

Short-term quality-of-life outcomes, assessed using the SF-36 and GERD-HRQOL instruments up to 4 months postoperatively, were similar between groups, with no signal of increased reflux symptoms in the pyloroplasty arm during early follow-up. 

The authors conclude that this study provides level I evidence supporting the routine addition of pyloroplasty during MIE or RAMIE to reduce early major postoperative complications and improve gastric emptying. Ongoing follow-up is focused on long-term outcomes, including durability of symptom control, bile reflux, and quality of life, with acknowledgment that larger multicenter trials will be necessary to confirm generalizability.