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Effectiveness of Methods for Pyloric Drainage in esophagecTomY: Botox vs. Pyloromyotomy (EMPTY Trial)

Phase 2 & 3

Waitlist Available

Led By Siva Raja, MD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* 18 years of age or older

* Undergoing elective esophagectomy (thoracoabdominal, Ivor-Lewis, McKeown)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months postoperatively

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Esophageal Achalasia
Esophageal Diseases
Pyloric Stenosis
Functional Esophageal Disorders
Esophageal Cancer Surgery
Esophagectomy
Gastroparesis
Esophageal Motility Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Gastroparesis Cardinal Symptom Index (GCSI) total score at 6 months postoperatively or prior to the first reintervention (which ever comes first)

Secondary study objectives

Cleveland Clinic Esophageal Questionnaire (CEQ) domain scores at 6-months postoperatively or prior to the first reintervention (whichever comes first)

Complications in the immediate post-operative period (within 30 days post-operatively)

Gastric emptying at 6 months postoperatively, measured by gastric emptying scintigraphy study (GES)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BotoxExperimental Treatment1 Intervention

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.

Group II: PyloromyotomyActive Control1 Intervention

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.

0 / 6Eligibility criteria met