A Clinical Study of Per Oral Endoscopic Myotomy (POEM) in Patients Suffering From Achalasia
Condition: Achalasia
MeSH terms: Esophageal Achalasia
Study type: Interventional

Summary: 
      This study evaluates the feasibility of endoscopic myotomy for achalasia. In achalasia, there
      is loss of relaxation of the lower esophageal sphincter (LES), as well as a higher baseline
      pressure in the LES. The most widespread treatment for this disease and the one that has the
      best long term results involves cutting the muscle layers of the lower esophagus and on the
      neighbouring stomach without injurying the underlying mucosa or inner layer of the esophageal
      wall. This is done during a surgery through the abdomen either with a big incision or more
      recently with the keyhole technique. This surgery has various potential complications, one of
      which being making a hole through the mucosa or not extending the cut on the muscle long
      enough to obtain adequate relaxation of the sphincter. The per oral endoscopic myotomy (POEM)
      is a new intervention that is done also under general anesthesia in the operating room;
      however, it involves no skin incisions and all the procedure is done through a fiber optic
      camera. It involves making a cut in the inner layer of the esophagus and then with cautery
      cut the muscle fibers responsible of the blockage and finally closing the initial opening
      with clips. In this study we will investigate the feasibility of this intervention both from
      a technical aspect as well as a logistical perspective given the local operating room
      constraints.
    

Detailed description: 
      All patients will have routine pre-operative EGD, manometry, barium swallow, ph-metry.
      Equally all patients will undergo Eckardt's and grading systems of symptom severity before
      and after the intervention. The patients will have a gastro-graffin swallow in the first day
      after the surgery.

      Procedure: Under general anesthesia upper endoscopy is performed using a standard single
      channel gastroscope. Submucosal injection with 10 ml saline with 1% methylen blue at the
      level of the mid esophagus is initially performed. A small longitudinal submucosal incision
      is created using a standard needle knife. For a sufficient entry point as well as submucosal
      tunnel, a dilating balloon is inserted submucosally via the created incision similar to the
      technique used in standard endoscopic submucosal dissection. The balloon is slightly inflated
      to allow sufficient entrance of the endoscope. The gastroscope is advanced into the
      submucosal space and the tunnel is created via needle knife or blunt dissection as
      appropriate. The tunnel is created distally and is stopped several centimeters beyond the
      lower esophageal sphincter (LES), which can easily be identified. Using flexible scissors, a
      triangle tip- or respectively an isolated tip-knife the clearly visible circular muscles are
      divided starting 4 cm above the LES extending 2 cm beyond the previously identified
      esophageal border. The longitudinal and serosal layers are left intact. Finally the mucosal
      entry is closed with standard endoscopic clips. Patients will receive standard postoperative
      care for surgical myotomy, including long-term follow-up.

      If for any reason the endoscopic treatment is unable to be completed or infeasible, a
      standard laparoscopic treatment will be performed.
    

Intervention name(s): Procedure: Per Oral Endoscopic Myotomy (POEM)
Intervention type(s): Procedure
Intervention description(s): lower esophageal sphincter muscle is sectioned through an unique endoscopic approach.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heller myotomy