NCT06721520 Effectiveness of Methods for Pyloric Drainage in esophagecTomY: Botox vs. Pyloromyotomy
| NCT ID | NCT06721520 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | The Cleveland Clinic |
| Condition | Esophageal Cancer Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2024-12-03 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 170 participants in total. It began in 2024-12-03 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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)
Contact & Investigator
Siva Raja, MD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT06721520 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Esophageal Cancer Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06721520 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06721520 currently recruiting?
Yes, NCT06721520 is actively recruiting participants. Contact the research team at connera5@ccf.org for enrollment information.
Where is the NCT06721520 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06721520 clinical trial?
NCT06721520 is sponsored by The Cleveland Clinic. The principal investigator is Siva Raja, MD at The Cleveland Clinic. The trial plans to enroll 170 participants.
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