Effectiveness of Methods for Pyloric Drainage in esophagecTomY: Botox vs. Pyloromyotomy

The goal of this pragmatic, registry-based, randomized clinical trial is to find out if using botulinum toxin (Botox) to help drain the stomach during an esophagectomy works as well as a pyloromyotomy in patients undergoing elective esophagectomy for benign or malignant esophageal disease. Both methods are intended to prevent problems with food emptying too slowly from the stomach (delayed gastric emptying), which can cause discomfort after surgery. The main question it aims to answer is: Is intrapyloric Botox injection as a drainage procedure during esophagectomy non-inferior in preventing symptoms of delayed gastric emptying at 6 months postoperatively compared to pyloromyotomy? Researchers will compare intrapyloric Botox injection to pyloromyotomy to see if Botox is non-inferior to pyloromyotomy in easing symptoms of delayed gastric emptying. Participants will: Be randomized to one of two treatment groups-either intrapyloric Botox injection or pyloromyotomy-during their esophagectomy. Complete surveys assessing digestive symptoms at standard postoperative follow-up intervals (3 months, 6 months, 1 year, and 2 years postoperatively). Undergo a standard gastric emptying study at 6 months after surgery.

NCT Number	NCT06721520
Lead Sponsor	The Cleveland Clinic
Conditions	Esophageal Cancer Surgery, Esophagectomy, Delayed Gastric Emptying Following Procedure, Esophageal Diseases, Esophageal Achalasia, Pylorus Dysfunction, Esophageal Dysmotility
Enrollment	170 participants
Start Date	2024-12-03
Primary Completion	2027-12-31 (estimated)
Study Completion	2028-05-31 (estimated)
Updated on ClinicalTrials.gov	2026-02-25