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

Launched by THE CLEVELAND CLINIC · Dec 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different methods to help with a common issue after esophageal cancer surgery called delayed gastric emptying, which means the stomach takes too long to empty food. The trial is comparing the use of Botox injections (a treatment that relaxes muscles) to a surgical procedure called pyloromyotomy, which helps food move more easily from the stomach. The main goal is to see if the Botox injections are just as effective as the surgery in reducing symptoms related to this problem six months after the surgery.

To participate in this trial, individuals must be at least 18 years old and scheduled for a specific type of surgery called an esophagectomy. They should be in good health and able to provide informed consent. Participants will be randomly assigned to receive either the Botox injection or the pyloromyotomy during their surgery and will complete surveys about their digestive symptoms at several follow-up visits after the surgery. Additionally, a test to check how well their stomach is emptying will be conducted six months later. This trial is currently recruiting participants, and it's important for eligible individuals to understand that their involvement will help researchers determine the best approach to support recovery after esophageal surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years of age or older
• • Undergoing elective esophagectomy (thoracoabdominal, Ivor-Lewis, McKeown)
• • Receiving a gastric conduit for alimentary reconstruction
• • Technically able to receive either intrapyloric Botox injection or pyloromyotomy as ultimately determined intraoperatively
• • Willing and able to provide informed consent
• • Willing and able to participate in long-term follow up including study visits and surveys
• Exclusion Criteria:
• • Undergoing emergent esophagectomy (e.g., for esophageal perforation)
• • Patients with underlying neuromuscular disease as Botox would be contraindicated (amyotrophic lateral sclerosis, myasthenia gravis, muscular dystrophies, Lambert-Eaton syndrome)
• • Patients undergoing left thoracoabdominal without left cervical neck incision (i.e., Sweet esophagectomy) - excluded due to the extent of gastric resection
• • Pregnancy
• • Allergy or hypersensitivity to botulinum toxin
• • Cannot feasibly receive both pyloric interventions as determined intraoperatively (e.g., patients with central obesity undergoing thoracoabdominal esophagectomy makes for a technically difficult pyloromyotomy)