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Completed

NCT Number: NCT01399476

Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia

This is a study of the safety and efficacy of a new surgical procedure using endoscopic instruments and a tunneling technique to reach the LES for dissection. We hypothesize that this technique provides an incisionless, less invasive option with similar functional outcome compared to standard Heller myotomy.

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Key information

Conditions

Achalasia Deglutition Disorders Digestive System Diseases Esophageal Achalasia Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Oregon Clinic

Portland, Oregon, 97210, United States

About this study

By the endoscopic creation of an esophageal submucosal tunnel the inner circular muscle layer can be easily visualized. In contrast to conventional Heller myotomy, the dissection of only the inner circular esophageal muscle layer leaves the outer longitudinal muscle layer intact. Thereby, post-interventional reflux disease should be avoided.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to undergo general anesthesia
  • Age > 18 yrs. of age and < 85 yrs. of age
  • Ability to give informed consent
  • Candidate for elective Heller myotomy

Exclusion criteria

  • Previous mediastinal or esophageal surgery
  • Contraindications for esophagogastroduodenoscopy
  • BMI > 45

Treatment and study plan

Endoscopic Myotomy

Procedure

Patients will receive the surgical procedure described in the summary (POEM).

Other names: POEM

Endoscopic Myotomy for treatment of achalasia

Procedure

Surgical procedure

Other names: POEM

Primary outcomes

  1. Improved quality of life as defined by survey pre and post surgery

    Time frame: six months

    patients diagnosed with achalasia will be given a quality of life survey before surgery and again six months after surgery.

Secondary outcomes

  1. Negative pH test

    Time frame: six months

    Patients will be required to have 24 hour pH testing after surgery.

  2. Bleeding

    Time frame: 1 year

    recorded blood loss will be taken during surgery.

Sponsors and collaborators

Lead sponsor

The Oregon Clinic

Other

Registry information

Official study title

Endoscopic Submucosal Tunnel Dissection for Endoluminal Partial Myotomy of the Lower Esophageal Sphincter for Achalasia

Acronym: POEM

Important dates

Study start
2010
Primary completion
2019
Study completion
2019
First posted
Jul 21, 2011
Registry last updated
Aug 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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