This phase III trial compares the results of two standard treatments, esophagectomy (removal of the esophagus) performed with a pyloroplasty (pyloric drainage procedure) and esophagectomy performed without a pyloroplasty. A pyloroplasty during esophagectomy may reduce the risk of aspiration (stomach contents spilling into the lungs).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03740542.
PRIMARY OBJECTIVE:
I. To study the value of the addition of a pyloroplasty procedure versus no pyloroplasty procedure during the performance of esophagectomy.
OUTLINE: Patients are randomized to 1 of 2 arms. The surgeon may reject the randomization if pyloroplasty cannot be performed or if pyloroplasty must be performed.
ARM I: Patients undergo esophagectomy with pyloroplasty.
ARM II: Patients undergo esophagectomy without pyloroplasty.
After completion of study treatment, patients are followed up at 5-10 days, then at 4, 6, and 12 months, and then periodically for up to 24 months.
Lead OrganizationUniversity of Pittsburgh Cancer Institute (UPCI)
Principal InvestigatorJames D. Luketich
