Peroral Endoscopic Myotomy (POEM) for Esophageal Motility
Condition: Achalasia
MeSH terms: Esophageal Achalasia
Study type: Interventional

Summary: 
      The investigators wish to monitor the adoption of a new, incisionless approach to performing
      a Heller myotomy for the surgical treatment of achalasia. The method, the Peroral Endoscopic
      Myotomy (POEM), will provide less-invasive treatment for esophageal achalasia, ideally
      providing similar if not better outcomes (safety and efficacy) as the Heller myotomy. The
      investigators hope to enroll 10 patients with a clinical diagnosis of achalasia who meet
      inclusion criteria.

      The POEM procedure has been done in many hospitals without any research associated with it.
      Dr. Ginsberg, Dr. Chandrasekhara and Dr. Kochman will perform the procedures after being
      trained. Dr. Ginsberg has personally witnessed the performance of 10 POEM procedures and has
      performed in a swine model. The PI is credentialed to initiate POEM at HUP with the first
      case to be proctored by an experienced operator. The PI will then proctor the other adopters.
      The investigators would like to evaluate the safety of it and the effectiveness of it. The
      investigators will use their symptom scores and radiology tests pre- and post-POEM to
      evaluate effectiveness.
    

Detailed description: 
      An esophageal motility disorder is when muscular contractions become discoordinated or weak
      and interfere with movement of food down the esophagus. Some esophageal motility disorders
      persist long enough to cause severe problems requiring surgical intervention. Achalasia, one
      subtype of esophageal motility disorder that is a rare disease, can be defined by the
      esophageal sphincter and muscle unable to relax or dilate. Left untreated, symptoms such as
      difficulty swallowing, regurgitation, heartburn, and chest pain may easily turn into
      complications such as severe weight loss, malnutrition, coughing, pulmonary infection,
      pneumonia, and perforation of the esophagus. Diagnosis of esophageal achalasia can be
      determined by esophageal manometry and/or barium swallow esophagram. Treatment for achalasia
      includes balloon dilation, botulinum toxin injection and surgical intervention. Balloon
      dilation is performed by inserting a balloon through the esophageal sphincter, inflating the
      balloon, disrupting the esophageal muscle. Botox has also been known to successfully relax
      spastic muscle contractions of achalasia through direct injection into the esophageal muscle.
      Unfortunately, each alternative to surgical treatment often requires repeated administration
      to improve the symptoms of achalasia. Traditional treatment of achalasia has included open
      abdominal or thoracic surgical procedures to cut valve muscles between the esophagus and
      stomach (Heller Myotomy). Laparoscopic multi-port Heller myotomies have become the preferred
      approach, requiring 4 smaller abdominal incisions for placement of laparoscope equipment.
      Results of this laparoscopic technique have proven that although 2/3 of the patient
      population was successfully treated, a subset of this group still need repeat surgical
      procedures or balloon dilation. Recently, single-incision laparoscopic Heller myotomies have
      produced favorable results, with a single umbilical incision preferential to
      multiple-incision laparoscopy. We propose adoption of a new, incisionless approach to
      performing a Heller myotomy for the surgical treatment of achalasia. The method, the Peroral
      Endoscopic Myotomy (POEM) is expected to provide a less-invasive treatment for esophageal
      achalasia, ideally providing similar if not better outcomes as the Heller myotomy and can be
      adopted safely and effectively at Penn Medicine.
    

Intervention name(s): POEM Procedure
Intervention type(s): Procedure
Intervention description(s): The procedure is performed under anesthesia.The procedure involves endoscopic electrosurgical dissection with an Olympus triangular tip knife.The myotomy is usually ~6cm long & averages 8-10cm. After the myotomy is performed the scope is withdrawn & inserted into the lumen to inspect the mucosa, ensure mucosal integrity & confirm easy passage of the endoscope through the LES consistent with an adequate myotomy. The mucosal entry site is usually 2-3cm long, & is closed with 5-10 endoscopic clips. Patients are hospitalized after procedure for observation.The patient is given IV-nutrition until post-operative day 1. An esophagram is obtained. If no loss of mucosal integrity or leak is noted, a liquid diet is started, which is continued for several days before initiating a solid diet.
Other intervention name(s): POEM; per oral endoscopic myotomy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: poem; per oral endoscopic myotomy; achalasia