Per-Oral Endoscopic Esophagomyotomy (POEM)
Condition: Achalasia
MeSH terms: Esophageal Achalasia
Study type: Interventional

Summary: 
      Achalasia is an esophageal motility disease that usually requires surgical intervention
      (esophagomyotomy). Laparoscopic techniques have reduced the morbidity associated with
      myotomy, but post-op GERD, wound infection, hernia and incisional pain are common. A new
      NOTES based procedure, per-oral endoscopic esophagomyotomy (POEM), has been developed that
      eliminates the need for skin incisions. All patients enrolled in this study, will have a
      thorough pre-op workup (including upper endoscopy, upper GI radiographs, high resolution
      esophageal manometry) confirming the diagnosis of achalasis at the Northwestern Esophageal
      Center. In this procedure, performed in the operating room under general anesthesia, a
      flexible endoscope is passed into the esophagus, a mucosal flap and a submucosal tunnel is
      created. This tunnel extends onto the stomach. The inner circular muscle layer of the lower
      esophagus and sphincter (LES) is identified and a myotomy is started 3-4cm distal to the
      mucosal flap and carried all the way onto the stomach. The mucosal opening is then closed
      with standard endoscopic clips. Patients will be admitted to the hospital and a gastrograffin
      esophagram will be performed on post-op day 1 to rule out esophageal leak. All patient will
      have a 2-3 week post-op appointment

      Patients with a confirmed diagnosis of achalasia may be offered POEM. The investigators
      hypothesize that POEM is feasible and safe and can effectively reduce residual LES pressure
      (as determined by manometry) and improve patients symptoms and quality of life.
    

Detailed description: 
      In this study, the investigators propose to use a surgical technique that eliminates skin
      incisions in patients undergoing esophagomyotomy. All patients will have a standard
      pre-operative esophageal work-up that may include upper endoscopy (EGD), endoscopic
      ultrasound (EUS), upper GI X-rays, high-resolution manometry, pH, FLIP and impedance
      measurement studies. Once the diagnosis of achalasia is confirmed, patients will be offered
      POEM or standard treatment for achalasia. All patients undergoing POEM will review and sign
      the study consent prior to their procedure.

      Operative and recovery room times as well as hospital length of stay will be collected.
      During the hospital stay, severity of pain, use of pain medications and complications will be
      recorded. Patients will remain NPO for 1 day. Post-op day 1, all patient will receive an
      esophagram to rule out esophageal perforation. If normal, patients will be started on clear
      liquids and advanced to a full liquid diet for 1 week post-op.

      Patients will return and be evaluated by their surgeon two weeks following their procedure.
      At this visit, any post-operative complications will be noted in the patient's medical
      record. Additionally at this visit and at the preoperative visit, patients will complete a
      standardized Quality of Life (QOL) assessment (i.e., SF-36). Perceived pain levels and type
      and frequency of pain medications will be recorded in the patient's medical record. Patients
      will then return at 6 weeks post-op to complete a second set of questionnaires and have a
      high resolution manometry performed to assess residual LES pressure.

      The potential advantages to the patients entered into this study include those mentioned
      above regarding elimination of post-operative wound infection and hernia but also the lack of
      abdominal incisions may reduce pain and recovery time and likely have a cosmetic advantage as
      well. Potential risks of this study include those associated with use of flexible endoscopic
      instruments include esophageal perforation, bleeding and sore throat. In addition, there is
      the possibility that there may be new, unanticipated complications from this modified
      surgical technique. Patient risks will be mitigated by having the procedure performed by a
      surgeon with expertise in laparoscopic esophageal surgery, flexible endoscopy and NOTES, as
      well as having involvement of a skilled interventional gastroenterologist if deemed
      necessary. The principle investigator (who will be the primary surgeon for all procedures)
      has performed multiple pre-clinical animal and cadaver POEM procedures and has traveled to
      Yokohama, Japan to observe human POEM cases performed by Dr. Haru Inoue.

      This feasibility study will initially evaluate the potential benefit, risks and impact on the
      patient's quality of life of this modified surgical technique in 20 patients. Once a
      standardized technique is established and risks are shown to be low, a prospective
      comparative evaluation is planned to compare this modified technique to the standard
      laparoscopic approach.
    

Intervention name(s): Per-Oral Endoscopic Esophagomyotomy
Intervention type(s): Procedure
Intervention description(s): In this procedure, performed in the operating room under general anesthesia, a flexible endoscope is passed into the esophagus, a mucosal flap and a submucosal tunnel is created. This tunnel extends onto the stomach. The inner circular muscle layer of the lower esophagus and sphincter (LES) is identified and a myotomy is started 3-4cm distal to the mucosal flap and carried all the way onto the stomach. The mucosal opening is then closed with standard endoscopic clips. Patients will be admitted to the hospital and a gastrograffin esophagram will be performed on post-op day 2 to rule out esophageal leak. A standardized symptom checklist will be used to assess patient's prior to hospital discharge and on post-op days 4 and 7. All patient will have a 2 week post-op appointment.
Other intervention name(s): POEM
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment