The Role That Peroral Endoscopic Myotomy (POEM) Could Play in the Treatment of Achalasia

Study Overview
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Brief Summary
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Based on the work of the Doctors at the Mayo Clinic Rochester, a new technique for a less invasive treatment for Achalasia has been developed. The purpose of this study is to decide the role this less invasive treatment (Peroral Endoscopic Myotomy) has in the treatment of patient's with achalasia.

Official Title
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Peroral Endoscopic Myotomy (POEM) for Treatment of Achalasia

Conditions
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Achalasia

Intervention / Treatment
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* Procedure: Peroral Endoscopic Myotomy a less invasive treatment for Achalasia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between the ages of 18 and 80 with achalasia diagnosed by a combination of compatible symptoms, barium esophagography and high resolution manometry. Exclusion Criteria: Patients who are poor surgical risks, have had previous treatment for achalasia or esophageal or gastric surgery, have an epiphrenic diverticulum or are unwilling to be followed in the protocol. Female patients are eligible if they are NOT pregnant or lactating AND ne of the following criteria is met: The patient is surgically sterile (by means of hysterectomy/bilateral tubal ligation) The patient is at least one year postmenopausal (no menses for 12 months). The patient is using a highly effective method of contraception, if childbearing potential, AND has a negative urine human chorionic gonadotropin beta subunit (ß HCG) pregnancy test result during Screening, and prior to trial drug administration. Highly effective methods of birth control are defined as those which result in a low failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner. Withdrawal, single- or double barrier methods (including condoms) and rhythm methods are NOT ACCEPTABLE methods of contraception for the purposes of this clinical trial due to the high incidence of contraceptive failures with these methods. Vulnerable populations, such as those with diminished mental acuity, will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peroral Endoscopic Myotomy (POEM)<br>Peroral Endoscopic Myotomy- a less invasive treatment for patients with Achalasia | Procedure: Peroral Endoscopic Myotomy a less invasive treatment for Achalasia<br>* In this study we will follow patients undergoing Peroral Endoscopic Myotomy at 1 and 6 months post surgery,1,2,3,4,and 5 years post surgery with esophageal high resolution Manometry and a Barium Esophagram when it is not standard of care. We will have you fill out a symptom questionnaire at each visit<br>* Other names: Esophageal Achalasia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events | Patients in this study, undergoing the Peroral Endoscopic Myotomy treatment for Achalasia, will be accessed at 1 month, 6 months, at 1-2-3-4 and year 5 post surgery. We will measure outcomes by number of adverse events, Eckardt symptom score, barium esophagram, and manometry studies. | 5 years post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eckardt symptom score | By following participants regularly and closely both by symptomatic and objective criteria, we will be able to determine factors that predict response to the POEMS procedure. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Less invasive treatment for Achalasia