Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia (POEM)

August 29, 2019 updated by: Lee Swanstrom, The Oregon Clinic

Endoscopic Submucosal Tunnel Dissection for Endoluminal Partial 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97210
        • The Oregon Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endoscopic Myotomy
Procedure: Endoscopic Myotomy
Patients will receive the surgical procedure described in the summary (POEM).
Other Names:
  • POEM
Procedure: Endoscopic Myotomy for treatment of achalasia
Surgical procedure
Other Names:
  • POEM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative pH test
Time Frame: six months
Patients will be required to have 24 hour pH testing after surgery.
six months
Bleeding
Time Frame: 1 year
recorded blood loss will be taken during surgery.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Oregon Clinic

Investigators

  • Principal Investigator: Lee L Swanstrom, MD, The Oregon Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

July 19, 2011

First Submitted That Met QC Criteria

July 20, 2011

First Posted (Estimate)

July 21, 2011

Study Record Updates

Last Update Posted (Actual)

August 30, 2019

Last Update Submitted That Met QC Criteria

August 29, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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