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NCT06721520 · ClinicalTrials.gov registry record · Phase 2
Effectiveness of Methods for Pyloric Drainage in esophagecTomY: Botox vs. Pyloromyotomy
A Phase 2 study of Esophagectomy and Esophageal Diseases, sponsored by The Cleveland Clinic.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 170
- Enrollment target
- 1
- Study location
NCT06721520 is a Phase 2 study of Esophagectomy and Esophageal Diseases that is actively recruiting participants, run by The Cleveland Clinic. The registered enrollment target is 170 participants, below the 2,114-participant average among 7 other Esophagectomy trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06721520, a Phase 2 study of Esophagectomy and Esophageal Diseases, is actively recruiting participants, sponsored by The Cleveland Clinic.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 170 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- BIOLOGICAL Botulinum Toxin A (Botox )
- PROCEDURE Pyloromyotomy
Study Locations (1)
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2024-12-03 |
| Est. Completion | 2028-05-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06721520
The ClinicalTrials.gov registry entry for NCT06721520 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 170 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,114-participant average among 7 other Esophagectomy trials with a reported enrollment target (92% lower). The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Esophagectomy appearing as the primary indexed condition, and to 2 interventions - of which Botulinum Toxin A (Botox ) is the first listed.
NCT06721520 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT06721520 about?
NCT06721520 is a clinical study titled "Effectiveness of Methods for Pyloric Drainage in esophagecTomY: Botox vs. Pyloromyotomy". 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 meth...
What is the current status of trial NCT06721520?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 170 participants. The study started on 2024-12-03. Estimated completion is 2028-05-31.
What conditions does trial NCT06721520 study?
This clinical trial studies the following conditions: Esophagectomy, Esophageal Diseases, Delayed Gastric Emptying Following Procedure, Esophageal Achalasia, Esophageal Cancer Surgery.
What interventions are being tested in trial NCT06721520?
The interventions under investigation include: Botulinum Toxin A (Botox ) (BIOLOGICAL), Pyloromyotomy (PROCEDURE).
Who is sponsoring clinical trial NCT06721520?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06721520 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.