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Tests treatment safety and results for Esophageal Cancer Surgery
Official title Effectiveness of Methods for Pyloric Drainage in esophagecTomY: Botox vs. Pyloromyotomy
ClinicalTrials.gov ID: NCT06721520
What this study is testing
What is Botulinum Toxin A (Botox )?
Botulinum Toxin A (Botox ) is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for esophageal cancer surgery.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Undergoing emergent esophagectomy (e.g., for esophageal perforation)
- Patients with underlying neuromuscular disease as Botox would be contraindicated (amyotrophic lateral sclerosis, myasthenia gravis, muscular...
- Patients undergoing left thoracoabdominal without left cervical neck incision (i.e., Sweet esophagectomy) - excluded due to the extent of gastric...
- Pregnancy
- Allergy or hypersensitivity to botulinum toxin
- Cannot feasibly receive both pyloric interventions as determined intraoperatively (e.g., patients with central obesity undergoing thoracoabdominal...
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.