Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT06721520

Effectiveness of Methods for Pyloric Drainage in esophagecTomY: Botox vs. Pyloromyotomy

Led by The Cleveland Clinic · Updated on 2026-02-25

170

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effectiveness of Methods for Pyloric Drainage in esophagecTomY: Botox vs. Pyloromyotomy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 determined during surgery
  • Willing and able to provide informed consent
  • Willing and able to participate in long-term follow-up including study visits and surveys
Not Eligible

You will not qualify if you...

  • Undergoing emergent esophagectomy (e.g., for esophageal perforation)
  • Having neuromuscular diseases like amyotrophic lateral sclerosis, myasthenia gravis, muscular dystrophies, or Lambert-Eaton syndrome
  • Undergoing left thoracoabdominal esophagectomy without left cervical neck incision (Sweet esophagectomy)
  • Pregnant
  • Allergy or hypersensitivity to botulinum toxin
  • Unable to receive both pyloric interventions as determined during surgery (e.g., due to central obesity making pyloromyotomy difficult)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

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Research Team

A

Andrew Conner, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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