Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2019-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Achalasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endoscopic Myotomy

Group Type EXPERIMENTAL

Endoscopic Myotomy

Intervention Type PROCEDURE

Patients will receive the surgical procedure described in the summary (POEM).

Endoscopic Myotomy for treatment of achalasia

Intervention Type PROCEDURE

Surgical procedure

Interventions

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Endoscopic Myotomy

Patients will receive the surgical procedure described in the summary (POEM).

Intervention Type PROCEDURE

Endoscopic Myotomy for treatment of achalasia

Surgical procedure

Intervention Type PROCEDURE

Other Intervention Names

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POEM POEM

Eligibility Criteria

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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