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Enrolling by invitation NCT02770859

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

Observational Achalasia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: POEM (Per Oral Endoscopic Myotomy).
Who it may be relevant to
Registry conditions: Achalasia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Procedure POEM (Per Oral Endoscopic Myotomy)
    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

Primary outcome measures

  • Improved Eckardt Score [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

18 years of age Referral for the treatment of Achalasia

Exclusion criteria

Less than 18 years of age; Absence of Achalasia

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • Indiana University Hospital — Indianapolis

Publications

  • DeWitt J, Stainko S, Perkins A, Rosenheck M, Al-Haddad M. Impact of prior endoscopic or surgical interventions on clinical outcomes after peroral endoscopic myotomy for achalasia. Surg Endosc. 2026 Jan;40(1):174-181. doi: 10.1007/s00464-025-12258-3. Epub 2025 Oct 6. PMID 41051511
  • Jacobs CC, Al-Haddad M, Stainko S, Perkins A, DeWitt JM. Prevalence and impact of opioid use in patients undergoing peroral endoscopic myotomy. Gastrointest Endosc. 2023 Apr;97(4):655-663.e2. doi: 10.1016/j.gie.2022.12.006. Epub 2022 Dec 9. PMID 36509112
  • DeWitt JM, Kessler WR, Wo JM, Stainko S, Perkins A, Dickason D, Al-Haddad MA, Siwiec R. Symptom Association for Gastroesophageal Reflux Disease by pH Monitoring After Peroral Endoscopic Myotomy. Am J Gastroenterol. 2022 Aug 1;117(8):1316-1319. doi: 10.14309/ajg.0000000000001801. Epub 2022 Apr 25. PMID 35467562
  • DeWitt JM, Siwiec R, Kessler WR, Wo JM, Stainko S, Picklesimer Doyle M, Perkins A, Dickason D, Al-Haddad MA. Comparison of functional lumen imaging probe and high-resolution manometry to assess response after peroral endoscopic myotomy. Gastrointest Endosc. 2022 May;95(5):855-863. doi: 10.1016/j.gie.2021.12.029. Epub 2022 Jan 1. PMID 34979118

Identifiers

NCT: NCT02770859 · 1410540149

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗