Per-Oral Endoscopic Myotomy (POEM) for the Treatment of Achalasia, Database Repository

• Conditions: Achalasia

• Registration Number: NCT02770859
• Lead Sponsor: Indiana University

Brief Summary

POEM (Per-Oral endoscopic myotomy (creating a muscle \[esophagus\] opening), an incision-less (no cutting of the surface of the body) endoscopic procedure, is an effective non-surgical alternative to release the muscle \& sphincter of the LES for the treatment of achalasia.

Detailed Description

Achalasia is a disease of the muscle of the esophagus (food tube) \& means "a failure to relax." The esophagus consists of 3 parts: the first part (uppermost part) is the upper esophageal sphincter (UES). The UES is a specialized ring of muscle which separates the esophagus from the throat, \& prevents food in the second part (body) of the esophagus from regurgitating into the throat. The third part of the esophagus (lower esophageal sphincter \[LES\]) also consists of a specialized ring of muscle which separates the body of the esophagus from the stomach, \& prevents food \& acid from regurgitating into the body of the esophagus. When achalasia is present, patients experience dysphasia (difficulty swallowing food, \& \[sometimes\] liquids), chest pain \& can experience recurrent pneumonia \& loss of weight.

Current treatments for achalasia include oral medications (calcium channel blockers) to relax the LES (difficult to swallow pill/capsule), dilation (stretching) of the LES, (temporary relief) \& Esophagomyotomy (general surgery to cut the LES).

POEM (Per-Oral endoscopic myotomy (creating a muscle \[esophagus\] opening), an incision-less (no cutting of the surface of the body) endoscopic procedure, is an effective non-surgical alternative to release the muscle \& sphincter of the LES for the treatment of achalasia.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-10-16
• Study First Submitted: 2016-05-10
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-02
• Primary Completion: 2040-01-31
• Study Completion: 2040-01-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

18 years of age Referral for the treatment of Achalasia

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Exclusion Criteria

Less than 18 years of age; Absence of Achalasia

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improved Eckardt Score	5 years	Consists of 4 questions used to characterize the severity of achalasia. The questions include symptoms related to dysphagia, chest pain, regurgitation, and weight loss. Each question is assigned a score from 0 to 3 based on the patient's self reported response.; The overall score ranges from 0-12, with anything less than 3 meaning no active symptoms, and anything higher than a 3 suggestive of active symptoms.

Trial Locations

Locations (1)

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States