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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Improved achalasia management. [ Time Frame: 5 years ]
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