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Botox injection could replace surgery for Post-Esophagectomy stomach issues

NCT ID NCT06721520

Disease control Sponsor: The Cleveland Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a Botox injection into the stomach valve works as well as a surgical cut to prevent food from emptying too slowly after esophagus removal. About 170 adults having elective esophagectomy will be randomly assigned to one of the two procedures. Researchers will track digestive symptoms and stomach emptying over two years to see if Botox is a good alternative.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Botulinum toxin A (Botox)
What this could lead to
If Botox works as well as surgery, it could offer a simpler, less invasive way to prevent stomach emptying problems after esophagus removal.
What could go wrong
This is a mid-stage trial with only 170 participants, so results may not apply to everyone. Botox effects are temporary, and the procedure still requires surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 170 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

achalasia dyskinesia of esophagus Esophageal Achalasia esophageal disorder gastroparesis pylorospasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Delayed gastric emptying following procedure Esophageal achalasia Esophageal cancer surgery Esophageal diseases Esophageal dysmotility Esophagectomy Pylorus dysfunction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

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