Intraoperative endoscopic pylorus dilatation during minimally invasive Ivor Lewis oesophagectomy to prevent delayed gastric conduit emptying (DGCE): protocol for the WIDE randomised controlled trial

Introduction Oesophageal cancer has a poor prognosis and oesophagectomy has increasingly adopted minimally invasive techniques, but delayed gastric conduit emptying (DGCE) still occurs in ~10–50% of patients, depending on the used diagnostic criteria and definitions. DGCE can cause serious complications, such as aspiration pneumonia, and it prolongs hospital stay and the overall morbidity of patients. Surgical pyloric drainage procedures (pyloroplasty or pyloromyotomy) have not clearly improved outcomes. Endoscopic pyloric balloon dilatation (EPBD) effectively treats established DGCE, and emerging evidence suggests that prophylactic EPBD may reduce its incidence. However, no randomised trial has evaluated intraoperative EPBD during minimally invasive oesophagectomy until now. The WIDE trial will test whether adding an EPBD during oesophagectomy can prevent early postoperative DGCE.Methods and analysis WIDE is a single-centre, double-blind randomised controlled trial, in which 116 adult patients undergoing minimally invasive Ivor Lewis oesophagectomy for oesophageal cancer are randomly assigned to intraoperative endoscopic pyloric balloon dilatation (30 mm EPBD) versus no pyloric intervention. Patients with prior gastric surgery, non-curative disease or American Society of Anesthesiologists class V are excluded. The EPBD is following induction of general anaesthesia and endotracheal intubation, and immediately prior to or concomitant with the start of the surgical procedure in the operating room. Control patients will receive standard surgery without any pyloric procedure. Patients and outcome assessors are blinded to the groups. The primary outcome is early DGCE after 5 and 10 days post-op, defined as nasogastric tube output ≥500 mL on postoperative day 5 or later and/or >100% increase in gastric conduit width on imaging (vs immediate post-op baseline). Key secondary outcomes include DGCE at 3 months, postoperative complication rates (eg, anastomotic leak, pneumonia, aspiration), recovery metrics (time to first bowel movement, time to resume solid food, vomiting episodes), length of hospital and ICU stay, and 3-month quality of life. Analysis will follow the intention-to-treat principle. A sample size of 104 patients (52 per arm) provides 80% power to detect a meaningful reduction in DGCE incidence (α=0.05). The target enrolment is 116 to allow for ~10% attrition.Ethics and dissemination The protocol (V.1.3) has been approved by the Northwestern and Central Switzerland Ethics Committee (EKNZ; BASEC 2025-01877). Written informed consent will be obtained from all participants. The trial is classified as a Category A (minimal-risk) study under the Swiss Human Research Act and Clinical Trials Ordinance (ClinO). Findings will be disseminated in peer-reviewed journals and conference presentations, as well as in our in-hospital journal in a lay version for patients.Trial registration number NCT07355374.