RecruitingPhase 2Phase 3NCT06721520

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

Comparative Effectiveness of Intrapyloric Botulinum Toxin Injection Versus Pyloromyotomy for Pyloric Drainage During Esophagectomy: A Registry-Based, Pragmatic Randomized Noninferiority Trial

Sponsor

The Cleveland Clinic

Enrollment

170 participants

Start Date

Dec 3, 2024

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two surgical techniques used to help the stomach empty properly after esophagectomy (surgery to remove part of the esophagus, usually for esophageal cancer). The two techniques are Botox injection into the valve between the stomach and small intestine versus a small surgical opening of that valve (pyloromyotomy). Both prevent a common complication called gastroparesis (delayed stomach emptying). **You may be eligible if...** - You are 18 years or older - You are scheduled for elective esophagectomy (thoracoabdominal, Ivor-Lewis, or McKeown type) - Your reconstruction involves using your stomach as a new food tube (gastric conduit) - You are willing to participate in long-term follow-up visits and surveys **You may NOT be eligible if...** - You are having emergency esophagectomy (e.g., for a ruptured esophagus) - You have a neuromuscular disease where Botox would be dangerous (such as ALS, myasthenia gravis, muscular dystrophy, or Lambert-Eaton syndrome) - You are having a specific type of esophagectomy (left thoracoabdominal without neck incision) because the stomach resection is too extensive - You are pregnant or allergic to botulinum toxin (Botox) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBotulinum 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.

PROCEDUREPyloromyotomy

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.