Esophageal Cancer Surgery study: Botulinum Toxin A vs Pyloromyotomy
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)?
An investigational injectable medicine being studied to help drain the stomach during 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 study compares Botox injection to a surgical cut (pyloromyotomy) to see if Botox is just as good at preventing slow stomach emptying after esophagectomy.
- Who it's for
- Adults scheduled for elective esophagectomy for benign or malignant esophageal disease.
- What's involved
- Participants will receive either a Botox injection or a pyloromyotomy during surgery, then fill out symptom surveys at 3, 6, 12, and 24 months and have a gastric emptying test at 6 months.
- Time commitment
- The study lasts up to 2 years after surgery, with follow‑up visits and tests at 3, 6, 12, and 24 months.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Cleveland, Ohio, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.