Procedure

Botox vs. Pyloromyotomy for Esophageal Cancer Surgery (EMPTY Trial)

Cleveland, OH

Phase 2 & 3

Recruiting

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

Receiving a gastric conduit for alimentary reconstruction

18 years of age or older

Must not have

Undergoing emergent esophagectomy (e.g., for esophageal perforation)

Patients undergoing left thoracoabdominal without left cervical neck incision (i.e., Sweet esophagectomy) - excluded due to the extent of gastric resection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months postoperatively

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine if using Botox to help drain the stomach during esophagectomy is as effective as another surgical procedure called pyloromyotomy in preventing delayed gastric emptying. The

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Who is the study for?

This trial is for patients having elective esophagectomy due to benign or malignant esophageal conditions. They should not have other factors that could affect gastric emptying. Participants will be chosen randomly to receive either Botox injections or pyloromyotomy during surgery and will complete follow-up surveys.Check my eligibility

What is being tested?

The study compares two stomach drainage methods after esophagectomy: intrapyloric Botox injection versus pyloromyotomy. It aims to determine if Botox is just as effective as pyloromyotomy in preventing delayed gastric emptying post-surgery.See study design

What are the potential side effects?

Possible side effects of the interventions may include discomfort at the injection site, potential infection, bleeding, or bruising for both procedures; specific risks related to Botox might involve muscle weakness.

Eligibility Criteria

Inclusion Criteria

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

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I am undergoing surgery to reconstruct my digestive tract.

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I am 18 years old or older.

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I am scheduled for surgery to remove part of my esophagus.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am having urgent surgery for a torn esophagus.

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I have not had a specific type of stomach surgery called Sweet esophagectomy.

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I do not have conditions like ALS, myasthenia gravis, muscular dystrophies, or Lambert-Eaton syndrome.

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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)

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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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Botulinum Toxin A (Botox )

2023

Completed Phase 4

~100

0 / 6Eligibility criteria met