Effectiveness of Methods for Pyloric Drainage in esophagecTomY: Botox vs. Pyloromyotomy
Recruiting
Phase 2
Phase 3
Interventional Study
Esophageal Cancer Surgery
Esophagectomy
Delayed Gastric Emptying Following Procedure
Esophageal Diseases
Esophageal Achalasia
Pylorus Dysfunction
Esophageal Dysmotility
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 170 (estimated)
- Sponsor
- The Cleveland Clinic · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
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 intraope…
Contacts