Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia

Not Applicable

Completed

• Conditions: Achalasia
• Interventions: Procedure: Endoscopic Myotomy; Procedure: Endoscopic Myotomy for treatment of achalasia

• Registration Number: NCT01399476
• Lead Sponsor: The Oregon Clinic

Brief 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.

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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-07-19
• Study First Submitted QC: 2011-07-20
• Study First Posted: 2011-07-21
• Status Verified: 2019-08
• Primary Completion: 2019-08
• Study Completion: 2019-08
• Last Update Submitted: 2019-08-29
• Last Update Posted: 2019-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endoscopic Myotomy	Endoscopic Myotomy	-
Endoscopic Myotomy	Endoscopic Myotomy for treatment of achalasia	-

Primary Outcome Measures

Name	Time	Method
Improved quality of life as defined by survey pre and post surgery	six months	patients diagnosed with achalasia will be given a quality of life survey before surgery and again six months after surgery.

Secondary Outcome Measures

Name	Time	Method
Negative pH test	six months	Patients will be required to have 24 hour pH testing after surgery.
Bleeding	1 year	recorded blood loss will be taken during surgery.

Trial Locations

Locations (1)

The Oregon Clinic; 🇺🇸 Portland, Oregon, United States