peroral endoscopic myotomy for Esophageal Achalasia

N/A

Waitlist Available

Led By Mouen A Khashab, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months and 12 months

Awards & highlights

No Placebo-Only Group

Summary

To compare the efficacy of peroral endoscopic myotomy and Botulinum toxin injection in spastic esophageal disorders.

Eligible Conditions

Esophageal Achalasia
Esophageal Spasm
Nutcracker Esophagus
Esophageal Motility Disorder

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Eckardt score

Secondary study objectives

changes in individual symptom scores

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

Group I: peroral endoscopic myotomyExperimental Treatment1 Intervention

Procedure/Surgery: peroral endoscopic myotomy. The procedure will be performed by an endoscopist (gastroenterologist or surgeon). General anesthesia will be started and upper endoscope will be inserted into the patient's mouth and advanced into the stomach. Endoscopic myotomy will be performed. Mucosal entry will then be closed using endoscopic clips or endoscopic suturing. All patients will recover from their procedures according to standard practice. They will remain nothing per oral (NPO) the night after the procedure and started on intravenous proton pump inhibitors. A gastrografin esophagram will be obtained the next day and if no evidence of leak, the diet will be advanced to a soft diet for two weeks. The patients will be evaluated by study coordinator/PI on a daily basis during their hospitalization.

Group II: Botulinum toxin injectionExperimental Treatment1 Intervention

Drug/Device: Botulinum toxin injection; Endoscopic Botulinum toxin (BTX) injection at lower esophagus; Upper endoscopy with Botulinum toxin injection. The procedure will be performed as an outpatient basis by an endoscopist. Sedation can be in form of conscious sedation, monitored anesthesia care or general anesthesia. An upper endoscope will be inserted into the patient's mouth and advanced into lower esophagus. Botulinum toxin (Botox@) 100 units 8-10 (25 units/mL) will be injected in 1-ml portion in each of four quadrants about 1 cm above the Z-line (the LES region). * At 1 month follow-up, patients who do not response to the first botox injection (Eckardt score \> 3) will receive the second botox injection. * At 3-month follow-up, POEM will be offered as a rescue therapy to both non-responders (Eckardt score \> 3 at 3-month follow-up after the procedure) and relapsers (Eckardt score ≤ 3 at 3-month follow-up but becomes \> 3 during the follow-up)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Botulinum toxin injection

2016

Completed Phase 3

~80

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