Recruiting
Phase 2
Phase 3

Botox vs. Pyloromyotomy

Sponsor:

The Cleveland Clinic

Code:

NCT06721520

Conditions

Esophageal Cancer Surgery

Esophagectomy

Delayed Gastric Emptying Following Procedure

Esophageal Diseases

Esophageal Achalasia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Botulinum Toxin A (Botox )

Pyloromyotomy

Study Details

Brief summary:

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

Esophageal Cancer Surgery

Esophagectomy

Delayed Gastric Emptying Following Procedure

Esophageal Diseases

Esophageal Achalasia

Study ID

NCT06721520

Start date

Dec 3, 2024

Status verified date

Feb, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Botox

Patients will be randomized to the intrapyloric Botox injection intervention arm intraoperatively just after the pylorus is identified and just prior to the time at which pyloric drainage would occur routinely, at which point it is feasible for the surgeon to perform either intervention.

active comparator: Pyloromyotomy

Patients will be randomized to the pyloromyotomy intervention arm intraoperatively just after the pylorus is identified and just prior to the time at which pyloric drainage would occur routinely, at which point it is feasible for the surgeon to perform either intervention.

Interventions

Botulinum Toxin A (Botox )

Patients randomized for intrapyloric Botox injection will undergo the following standard procedure: 100 units of Botox are dissolved in 10 mL normal saline. After identifying the pylorus, the 10 mL of Botox solution is injected intramuscularly at the anterior pyloric ring in 2 separate areas and in 1 area on each side of the pyloric ring.

Pyloromyotomy

Patients randomized for pyloromyotomy will undergo standard pyloromyotomy as follows: after identifying the pylorus, a 2-cm longitudinal incision is made with Metzenbaum or Mayo scissors on the anterior pylorus, centered on the pyloric ring. The incision extends through the serosa and muscular layers to expose the submucosa and mucosa, which is left intact. The cut muscle is spread apart until the submucosa bulges up to the level of the cut serosa. Care is taken to avoid perforation, and the surgeon confirms no mucosal perforation at the end of the procedure. If a perforation is encountered, it will be repaired primarily.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Andrew Conner, MD

216-316-6644connera5@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Andrew Conner, MD

216-316-6644connera5@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Keywords

  • Esophagectomy
  • Delayed gastric emptying
  • Delayed conduit emptying
  • Botox
  • botulinum toxin
  • Pyloromyotomy
  • Pyloric drainage

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-02-25.