Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia

Achalasia Clinical Trial

— POEM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01399476
• Other study ID #: 1056
• Status: Completed
• Phase: N/A
• Start date: September 2010
• Est. completion date: August 2019

Study information

• Verified date: August 2019
• Source: The Oregon Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia

Intervention

Procedure:
• Endoscopic Myotomy
Patients will receive the surgical procedure described in the summary (POEM).
• Endoscopic Myotomy for treatment of achalasia
Surgical procedure

Locations

Country	Name	City	State
United States	The Oregon Clinic	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
The Oregon Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved quality of life as defined by survey pre and post surgery	patients diagnosed with achalasia will be given a quality of life survey before surgery and again six months after surgery.	six months
Secondary	Negative pH test	Patients will be required to have 24 hour pH testing after surgery.	six months
Secondary	Bleeding	recorded blood loss will be taken during surgery.	1 year