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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational [Patient Registry]

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

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 Summary:

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.


Sponsor: Indiana University

Current Primary Outcome: This is a tracking system for specific treatment modalities, and data to determine the impact of endoscopic ultrasound for patients with achalasia. Achalasia is a disease of the muscle of the esophagus (food tube) & means "a failure to relax." [ Time Frame: 5 years ]

Data will be collected for research purposes only, to determine the clinical impact of endoscopic ultrasound treatment of achalasia


Original Primary Outcome: Same as current

Current Secondary Outcome: Improved achalasia management. [ Time Frame: 5 years ]

The purpose of tracking this data will also help the physicians to better understand the patient's condition and disease process, which may lead to improved standard of care and improved patient management.


Original Secondary Outcome: Same as current

Information By: Indiana University

Dates:
Date Received: May 10, 2016
Date Started: October 2014
Date Completion: January 2020
Last Updated: May 10, 2016
Last Verified: May 2016