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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01399476
Recruitment Status : Recruiting
First Posted : July 21, 2011
Last Update Posted : January 2, 2018
Information provided by (Responsible Party):
Lee Swanstrom, The Oregon Clinic

July 19, 2011
July 21, 2011
January 2, 2018
September 2010
September 2018   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01399476 on Archive Site
  • Negative pH test [ Time Frame: six months ]
    Patients will be required to have 24 hour pH testing after surgery.
  • Bleeding [ Time Frame: 1 year ]
    recorded blood loss will be taken during surgery.
Same as current
Not Provided
Not Provided
Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia
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.
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.
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Procedure: Endoscopic Myotomy
    Patients will receive the surgical procedure described in the summary (POEM).
    Other Name: POEM
  • Procedure: Endoscopic Myotomy for treatment of achalasia
    Surgical procedure
    Other Name: POEM
Experimental: Endoscopic Myotomy
  • Procedure: Endoscopic Myotomy
  • Procedure: Endoscopic Myotomy for treatment of achalasia
Kurian AA, Dunst CM, Sharata A, Bhayani NH, Reavis KM, Swanström LL. Peroral endoscopic esophageal myotomy: defining the learning curve. Gastrointest Endosc. 2013 May;77(5):719-25. doi: 10.1016/j.gie.2012.12.006. Epub 2013 Feb 5.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2018
September 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
Contact: Angi B Gill, RN 503-281-0561
United States
Not Provided
Not Provided
Lee Swanstrom, The Oregon Clinic
The Oregon Clinic
Not Provided
Principal Investigator: Lee L Swanstrom, MD The Oregon Clinic
The Oregon Clinic
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP