POEM Anterior Versus Posterior Approach
Condition: Achalasia
MeSH terms: Esophageal Achalasia
Study type: Interventional

Summary: 
      Per-oral endoscopic myotomy (POEM) is an incisionless procedure used to treat esophageal
      achalasia, performed by GI endoscopist without cutting any surface of the human body. The
      main constituent of the procedure is the myotomy part, through which the endoscopist cuts the
      muscle fibers in the submucosa. Since this procedure is completely new to the area of
      treatment of achalasia, it is unknown whether a posterior or an anterior myotomy is better in
      relieving the symptoms. Thenceforth, this study aims at randomizing patients with achalasia
      presenting for POEM to getting either the posterior or the anterior myotomy. Patients will be
      followed up for symptoms and complications; data will be extracted and the appropriate
      analysis will be employed to determine if there is any difference of outcome between the two
      techniques of myotomy.
    

Detailed description: 
      Peroral Endoscopic Myotomy (POEM) is an effective, minimally-invasive treatment for achalasia
      that has been adopted over the past few years. As more programs attempt to adopt the novel
      technique, there is an increased need for trials to help guide the growth of the procedure.
      Review of the current literature reveals that most endoscopists prefer an anterior approach,
      with an incision in the anterior/ anterolateral wall of the esophagus. This approach has been
      used with tremendous success in decreasing the symptoms of dysphagia and lowering esophageal
      sphincter (LES) pressure since the first description of the procedure in humans in 2010.
      However, it can be technically challenging in patients with anterior scarring from prior
      surgery or radiation, in whom a posterior approach has typically been used. Alternatively,
      the posterior approach, with incision in the posterolateral wall of the esophagus, has been
      adopted with great success by several endoscopists as the primary approach to myotomy.
      Reports involving the posterior approach have also shown significant symptom relief as
      defined by symptoms score (Eckardt score) < 3, decreased LES pressure, and low complication
      rates.

      However, despite high rates of technical and clinical success, the posterior approach has not
      been as widely adopted as the anterior approach. Without comparison of the two approaches in
      terms of efficacy and safety, the optimal technique to myotomy for POEM is yet to be defined.
      The investigators main hypothesis is that the posterior myotomy is as efficacious as the
      anterior myotomy in terms of improvement of achalasia symptoms as indicated by reduction in
      the Eckardt score and LES pressure. Adaptation of both techniques may increase options in
      approach for routine POEM and increase the number of patients that are able to undergo the
      procedure, thereby promoting its applicability.
    

Intervention name(s): Peroral Endoscopic Myotomy
Intervention type(s): Procedure
Intervention description(s): The intervention is the POEM procedure performed by either anterior approach or posterior approach orientation of the incision for mucosal entry.
Other intervention name(s): POEM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment