Comparing Botox and surgery for stomach drainage during esophagectomy
Comparative Effectiveness of Intrapyloric Botulinum Toxin Injection Versus Pyloromyotomy for Pyloric Drainage During Esophagectomy: A Registry-Based, Pragmatic Randomized Noninferiority Trial
This study is testing whether Botox injections can help people who have had esophagus surgery manage delayed stomach emptying just as well as surgery can.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06721520 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are scheduled for elective esophagectomy and can receive either treatment method.
Not a fit: Patients undergoing emergency esophagectomy or those with contraindications to Botox, such as certain neuromuscular diseases, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive alternative to surgery for managing delayed gastric emptying in patients undergoing esophagectomy.
How similar studies have performed: While the use of Botox for gastric drainage is explored in other contexts, this specific comparison with pyloromyotomy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Cleveland, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.