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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Achalasia	Procedure: Peroral Endoscopic Myotomy a less invasive treatment for Achalasia	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	20 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Peroral Endoscopic Myotomy (POEM) for Treatment of Achalasia
Study Start Date :	January 2012
Actual Primary Completion Date :	January 2016
Actual Study Completion Date :	January 2016

Arms and Interventions

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Arm

Intervention/treatment

Experimental: Peroral Endoscopic Myotomy (POEM); Peroral Endoscopic Myotomy- a less invasive treatment for patients with Achalasia

Procedure: Peroral Endoscopic Myotomy a less invasive treatment for Achalasia; 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; Other Names: Achalasia; Heller myotomy; Dysphagia; Peroral Endoscopic Myotomy; Disease of the muscle of the esophagus.; Disorder of the swallowing tube.; Esophageal Motility Disorders; Esophageal Achalasia

Outcome Measures

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Primary Outcome Measures :

1. Number of participants with adverse events [ Time Frame: 5 years post surgery ]
   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.

Secondary Outcome Measures :

1. Eckardt symptom score [ Time Frame: 5 years ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:	David Katzka, MD	Mayo Clinic

More Information

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Responsible Party:	David A. Katzka, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT01584635 History of Changes
Other Study ID Numbers:	11-005252
First Posted:	April 25, 2012
Last Update Posted:	October 31, 2016
Last Verified:	October 2016

Keywords provided by David A. Katzka, Mayo Clinic:

Less invasive treatment for Achalasia

Additional relevant MeSH terms:

Esophageal Achalasia; Esophageal Motility Disorders; Deglutition Disorders	Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases