NCT06721520 (EMPTY) is a Phase 2, PHASE3 clinical trial of Botulinum Toxin A (Botox ) in Esophageal Cancer Surgery, sponsored by The Cleveland Clinic.

Who is sponsoring NCT06721520?

NCT06721520 is sponsored by The Cleveland Clinic.

What drugs are being tested in NCT06721520?

Interventions in NCT06721520: Botulinum Toxin A (Botox ), Pyloromyotomy.

What condition does NCT06721520 study?

NCT06721520 studies Esophageal Cancer Surgery, Esophagectomy, Delayed Gastric Emptying Following Procedure, Esophageal Diseases, Esophageal Achalasia, Pylorus Dysfunction, Esophageal Dysmotility.

Is NCT06721520 still recruiting?

NCT06721520 is currently recruiting now. Last updated 25 February 2026.

Last reviewed 2026-02-25 · How we verify

NCT06721520: EMPTY

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 2, PHASE3 Last updated 25 February 2026

What this trial tests

Phase 2, PHASE3 trial testing Botulinum Toxin A (Botox ) in Esophageal Cancer Surgery in 170 participants. Currently enrolling.

Timeline

3 December 2024

Primary endpoint
31 December 2027

31 May 2028

Quick facts

Lead sponsor	The Cleveland Clinic
Phase	Phase 2, PHASE3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	170
Start date	3 December 2024
Primary completion	31 December 2027
Estimated completion	31 May 2028
Sites	1 location across United States

Drugs / interventions tested

Botulinum Toxin A (Botox ) — full drug profile →
Pyloromyotomy

Conditions studied

Esophageal Cancer Surgery — all drugs for Esophageal Cancer Surgery →
Esophagectomy — all drugs for Esophagectomy →
Delayed Gastric Emptying Following Procedure — all drugs for Delayed Gastric Emptying Following Procedure →
Esophageal Diseases — all drugs for Esophageal Diseases →

Sponsor

The Cleveland Clinic

Who can join

18 and older, any sex, with Esophageal Cancer Surgery or Esophagectomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Botulinum Toxin A (Botox )

Trials testing the same drug.

NCT06840730 — Efficiency of Botulinum Toxin type-a in the Management of the Myofascial Pain · NA · completed
NCT06724250 — Biofeedback Therapy Versus Botox Injection in Treatment of Dyssynergic Defecation. · Phase 4 · completed

Other The Cleveland Clinic trials

Trials by the same sponsor.

NCT07218198 — Clinical Decision Support Tool for the Treatment of Uncontrolled Hypertension · NA · not yet recruiting
NCT07442747 — Neural Mechanisms of Aerobic Exercise Benefits in PD With DBS · NA · not yet recruiting
NCT07471464 — Centered Surgery - Preoperative Counseling and Patient Satisfaction · recruiting
NCT07073963 — Virtual Patient Groups for Sarcoidosis Associated Fatigue · NA · recruiting
NCT07363343 — Nifedipine and Enalapril vs Nifedipine and Labetalol for the Treatment of Postpartum Hypertension Study · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06721520 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The Cleveland Clinic
Last refreshed: 25 February 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06721520.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing