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Botox vs. Pyloromyotomy for Stomach Drainage After Esophagectomy

This study is looking at two ways to help your stomach empty properly after an esophagectomy (surgery to remove part of your esophagus, the tube that carries food to your stomach). The goal is to see if injecting Botulinum Toxin A (Botox) into the pylorus (the opening from your stomach to your small intestine) works as well as a pyloromyotomy (a surgical cut in the pylorus). Both methods aim to prevent delayed gastric emptying, which can cause discomfort after surgery. You may be able to join if you are 18 or older, having an esophagectomy, and can receive either procedure. The study will compare how well each method prevents symptoms of delayed gastric emptying at 6 months after surgery.

Study design
This is a randomized study comparing two standard procedures, Botox injection or pyloromyotomy, with 170 participants. It is a single-blinded trial, meaning you won't know which treatment you receive.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 6 months after your surgery, or until your first reintervention for delayed gastric emptying symptoms, whichever comes first.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06721520

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

Recruiting
PHASE2Ages 18+InterventionalPrevention
The Cleveland Clinic
~170 participants
Updated 2026-02-25 on ClinicalTrials.gov
What's tested:Botulinum Toxin A (Botox )Pyloromyotomy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Gastroparesis Cardinal Symptom Index (GCSI) total score at 6 months postoperatively or prior to the first reintervention (which ever comes first)
Measured over 6 months postoperatively or prior to the first pyloric reintervention to treat symptoms of delayed gastric emptying postoperatively (whichever comes first)

Conditions

Esophageal Cancer Surgery
Esophagectomy
Delayed Gastric Emptying Following Procedure
Esophageal Diseases
Esophageal Achalasia
Pylorus Dysfunction
Esophageal Dysmotility

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NCT06721520

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cleveland Clinic

    Cleveland, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Siva Raja, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

Who to contact

Andrew Conner, MD
[email protected]
216-316-6644
Email the study team

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Gastroparesis Cardinal Symptom Index (GCSI) total score at 6 months postoperatively or prior to the first reintervention (which ever comes first)6 months postoperatively or prior to the first pyloric reintervention to treat symptoms of delayed gastric emptying postoperatively (whichever comes first)

    The GCSI is a validated 9-item instrument used to quantify severity of symptoms associated with delayed gastric emptying. The GCSI is based on three subscales, which measure cardinal symptoms related to delayed gastric emptying: postprandial fullness/early satiety (4 items), nausea/vomiting (3 items), and bloating (2 items). A 6-point Likert-type response scale, ranging from 0 (none) to 5 (very severe) is used for rating the severity of each symptom item, with a recall period of 2 weeks. Subscale scores are calculated by averaging across the item scores within each subscale. The range of subscale scores is 0 to 5, where higher scores reflect perception of worse symptom severity. The GCSI total score is constructed as the average of the three symptom subscales scores. GCSI. GSCI scores will be obtained preoperatively and at 3-month, 6-month, 1-year, and 2-year follow up, with 6 months as the specific time point for our primary endpoint.