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

The Oregon Clinic

Status: Completed

Conditions: Achalasia

Treatments: Procedure: Endoscopic Myotomy for treatment of achalasia; Procedure: Endoscopic Myotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01399476

1056

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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350 participants in 1 patient group

Endoscopic Myotomy

Experimental group

Treatment:

Procedure: Endoscopic Myotomy

Procedure: Endoscopic Myotomy for treatment of achalasia