Comparing Botox Injection and Pyloromyotomy for Stomach Drainage During Esophagectomy Surgery A Randomized Trial to Prevent Delayed Stomach Emptying After Esophageal Surgery

What this Trial Is About

Researchers are evaluating two methods to help drain the stomach during esophagectomy surgery in patients with benign or malignant esophageal diseases. The study compares the use of intrapyloric botulinum toxin Botox injection versus pyloromyotomy to see if Botox is not worse than pyloromyotomy in preventing delayed gastric emptying symptoms six months after surgery. This trial is a randomized, pragmatic, registry-based clinical study conducted at a single institution. Participants will be randomly assigned during surgery to receive either the Botox injection or pyloromyotomy. For Botox, 100 units dissolved in saline are injected into four areas of the pyloric muscle. For pyloromyotomy, a surgical incision is made in the pyloric muscle to allow better emptying. Both procedures occur after the pylorus is identified during esophagectomy. The study includes two treatment arms with equal allocation. Participants will complete surveys assessing digestive symptoms at 3 months, 6 months, 1 year, and 2 years after surgery. A gastric emptying scan will be performed at 6 months to measure stomach emptying. Researchers will monitor symptoms using the Gastroparesis Cardinal Symptom Index GCSI and other questionnaires, track complications within 30 days, and record any pyloric reinterventions up to 24 months. The study aims to follow patients long term to assess outcomes and safety.

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