Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy for Gastrointestinal Motility Disorders

Study Overview
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Brief Summary
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This is prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.

Detailed Description
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This is prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed. This study will enroll 600 subjects over the next 4 to 5 years.

Official Title
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Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy for Gastrointestinal Motility Disorders

Conditions
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Achalasia, Esophageal Spasm, Diffuse, Gastroparesis, Swallowing Disorder, Zenker Diverticulum

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older. Scheduled to undergo POEM Exclusion Criteria: Any contraindication to performing endoscopy. Participation in another research protocol that could interfere or influence the outcomes measures of the present study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Esophageal POEM<br>Data will be collected for patients under going standard of care Esophageal POEM (E-POEM) | |
| Gastric POEM<br>Data will be collected for patients under going standard of care Gastric POEM (G-POEM) | |
| Zenker's POEM<br>Data will be collected for patients under going standard of care Zenker's diverticulum POEM (Z-POEM) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post procedural Reflux Rate | Rate of Long-Term Clinical Success and Post-procedural Reflux Rate Among Patients with Esophageal Dysmotility Undergoing POEM | 12 months | 
| Long-Term Clinical Efficacy of G-POEM for the management of medically refractory gastroparesis | The main outcome of the study is to evaluate the proportion of patients who have clinical response to GPOEM. Clinical response is measured by the validated symptom assessment tool (gastroparesis cardinal symptom index - GCSI). Patients with a decrease in GCSI by one or more point will be defined as having a clinical response. | 12 months | 
| Long-Term Clinical Efficacy of Z-POEM for the management of Zenker's Diverticulum and Rate of Recurrence | The main outcome of this study is to evaluate rate of recurrence of symptoms after Z-POEM for Zenker's diverticulum. Recurrence is defined as a return of patient's symptoms (dysphagia, odynophagia) at the time of clinic follow-up. | 12 months | 
| Evaluate the efficacy of POEM for the management of gastrointestinal disease for esophageal motility. | The main outcome measure is to evaluate the long-term efficacy of POEM for esophageal motility disorders. Efficacy or clinical response is usually assessed using the Eckardt score. An Eckardt score of < 3 is traditionally defined as treatment response following POEM. | 12 months |