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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Biological
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Contact Information
Primary
Andrew Conner, MD
connera5@ccf.org
216-316-6644
Time Frame
Start Date: 2024-12-03
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 170
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: The Cleveland Clinic

This content was sourced from clinicaltrials.gov