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

NCT ID: NCT02770859

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-16
• Study Completion Date: 2040-01-31

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.

Conditions

Achalasia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

POEM

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

John DeWitt

Director, Endoscopic Ultrasound

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John M DeWitt, M.D.

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Indiana University Hospital

Indianapolis, Indiana, United States

Countries

United States

References

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. 2025 Oct 6. doi: 10.1007/s00464-025-12258-3. Online ahead of print.

Reference Type: DERIVED

PMID: 41051511 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36509112 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35467562 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34979118 (View on PubMed)

Other Identifiers

1410540149

Identifier Type: -

Identifier Source: org_study_id