Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT06721520
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06721520
Study Brief:
Protocol Section:
NCT06721520