Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Esophagectomy

A Phase III Randomized Trial of Pyloroplasty Versus No Pyloroplasty in Patients Undergoing Esophagectomy

This research study is a phase III randomized trial to study the value of the addition of a pyloroplasty procedure versus no pyloroplasty procedure during the performance of esophagectomy. Pyloroplasty is a type of pyloric drainage procedure.

Patients selected for enrollment in this study will be adults (18-85 years of age) that have been scheduled for exploration, and possible esophagectomy. Prior to surgery, patients will be randomized to one of two groups. Group A will have a pyloroplasty performed as part of the esophagectomy procedure. Group B will not have a pyloroplasty performed. Postoperative patient outcomes will be assessed for 24 months.

Inclusion Criteria:

• Subjects must be willing to undergo esophagectomy for benign or malignant condition
• Women and men 18-85 years of age
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Stomach is used as conduit

Exclusion Criteria:

• Previous operations of the pylorus
• Previous gastric resection
• Previous gastric bypass
• Patients who are unable to tolerate surgery
• Participants may be enrolled and randomized on the study but may be excluded at the time of the surgery because of findings by the surgeon that preclude performing esophagectomy, or using stomach as a conduit or findings which preclude following the randomized arm.
• Age <18 years of age or > 85 years of age
• BMI > 50
• Liver cirrhosis or liver failure at physician's discretion