Comparing Botox and surgery for stomach drainage during esophagectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of botulinum toxin (Botox) versus pyloromyotomy for pyloric drainage in patients undergoing elective esophagectomy. It is a pragmatic, registry-based, randomized clinical trial that will compare outcomes related to delayed gastric emptying after surgery. Participants will be randomly assigned to receive either intrapyloric Botox injection or pyloromyotomy, with the goal of determining if Botox is as effective as the surgical method in alleviating symptoms of delayed gastric emptying at six months postoperatively.

Why it matters

Who can join: the full rules

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)

Where it's running

• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Siva Raja, MD — The Cleveland Clinic
• Study coordinator: Andrew Conner, MD
• Email: connera5@ccf.org
• Phone: 216-316-6644

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.