NCT06721520RecruitingPhase 2/3
Effectiveness of Methods for Pyloric Drainage in esophagecTomY: Botox vs. Pyloromyotomy
Comparative Effectiveness of Intrapyloric Botulinum Toxin Injection Versus Pyloromyotomy for Pyloric Drainage During Esophagectomy: A Registry-Based, Pragmatic Randomized Noninferiority Trial
Source: ClinicalTrials.gov · Last updated 25 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 170 (estimated)
- First submitted
- 3 Dec 2024
- Start date
- 3 Dec 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- The Cleveland Clinic
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06721520
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 170
- From 3 Dec 2024 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients undergoing left thoracoabdominal without left cervical neck incision (i.e., Sweet esophagectomy) - excluded due to the extent of gastric resection
Other illness
- 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)
- Allergy or hypersensitivity to botulinum toxin
Other
- Pregnancy
- Cannot feasibly receive both pyloric interventions as determined intraoperatively (e.g., patients with central obesity undergoing thoracoabdominal esophagectomy makes for a technically difficult pyloromyotomy)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.