Transoral Incisionless Fundoplication in Post-POEM GERD
Condition: Swallowing Disorders; Achalasia; Outlet Obstruction, Gastric; Diffuse Esophageal Spasm
MeSH terms: Deglutition Disorders; Esophageal Spasm, Diffuse; Esophageal Motility Disorders; Gastric Outlet Obstruction
Study type: Observational [Patient Registry]

Summary: 
      POEM (per oral endoscopic myotomy) is effective for the treatment of swallowing disorders but
      can induce acid reflux. If acid reflux remains untreated in this situation, it can lead to
      significant problems. Thus, minimizing abnormal acid exposure after POEM is very important.
      Typically, this is done with acid suppression medications such as Prilosec or Nexium.
      However, long term acid suppression medication has been linked to possible long-term
      complications. Transoral incisionless fundoplication (TIF) has been approved for the
      treatment of reflux, but its use in reflux after POEM has not been investigated in detail. We
      hypothesize TIF will be able to decrease the amount of acid reflux in to the esophagus,
      thereby allowing patients to remain off of acid suppression medications.

      Once enrolled into the study, you will undergo the POEM procedure. 3 months after the
      procedure we will assess for abnormal reflux via questionnaires and diagnostic testing as
      part of the standard management post POEM. If there is evidence of abnormal reflux, the TIF
      procedure will be performed. 3 months after the TIF, you will have similar testing again to
      document resolution in abnormal acid reflux.You will be followed for 12 months as part of the
      study. If at the 3 month mark, there is no evidence of abnormal reflux, you will neither be
      placed on PPI nor undergo TIF and will be followed for 12 months to assess for abnormal
      reflux
    

Detailed description: 
      EGD (esophagogastroduodenoscopy) is a safe procedure used extensively to evaluate the
      esophagus, stomach and small intestine. With the assistance of the anesthesiology team, we
      will put you to sleep partially to minimize discomfort during the insertion of the endoscopy.
      This is normally how this procedure is performed and deemed very safe. Potential
      complications include breathing problems, holes in the intestine, and bleeding. These occur
      very infrequently. In our study, EGD will be used at three checkpoints (all of which are part
      of standard of care):

        1. at the time of POEM to rule out other unusual structural abnormalities

        2. at 3 months during measurement of acid exposure in the esophagus via Bravo pH

        3. 3 months after TIF placement (6 months after enrollment and POEM) to document resolution
           in acid reflux.

      Esophageal manometry is a non-endoscopic procedure that involves using a safe numbing cream
      to allow passage of the manometry catheter from the nose down to the end of the esophagus.
      Different measurements are taken from the catheter and the catheter is then removed. This is
      a standard of care procedure in the evaluation of patients with esophageal
      motility/swallowing disorders. It will be used in the following settings and all are part of
      standard of care:

        1. 3 months after POEM as part of standard of care to assess improvement in the swallowing

        2. 3 months after TIF (6 months post POEM) only if swallowing issues reappear.

      Bravo pH study is used to assess abnormal acid reflux and is considered gold standard in
      identifying the degree of acid reflux. It is standard of care for this procedure to be
      performed in patients with suspected acid reflux and post-POEM to assess need for long term
      acid suppression. It involves performing an endoscopy first, followed by deployment and
      implantation of the Bravo pH capsule into the end of the esophagus. Risks include bleeding,
      injury to the esophagus or dislodgment of the capsule. However, these are rare instances.

      POEM Those enrolled into the study will undergo a diagnostic endoscopy at the same allotted
      time as the POEM. It will be explained to you in detail but involves endoscopically cutting
      the muscle at the end of the esophagus, called a myotomy. It is less invasive than its
      surgical equivalent Heller's myotomy, but equally effective. Two endoscopist (one with
      extensive experience in POEM and the other with formal training in POEM) will be performing
      the actual POEM procedures.

      TIF The TIF procedure is performed using the FDA approved EsophyX-Z device
      (EndoGastricSolutions, Redmond, Wash, USA). It has been shown to be effective in the
      management of acid reflux in patients who fail acid suppression therapy or in patients who
      would like to avoid long term acid suppression with acid suppression therapy due to the
      potential side effects. It involves the use of a flexible suturing apparatus that fits over
      the endoscope and is used to create an artificial wrap around the end of the esophagus,
      thereby mimicking the effects of the typical surgical wrap. In the right setting it is as
      effective as its surgical counterpart but less invasive. Due to the incisionless approach,
      patients undergoing TIF experience less discomfort and faster recovery than those undergoing
      traditional anti-reflux surgery.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with confirmed indications for POEM (achalasia, jackhammer esophagus, EGJOO,
        diffuse esophageal spasm) will be identified as potential study patients. These patients
        will undergo objective testing and will be required to complete subjective questionnaires
        for achalasia and GERD as part of the standard work up (off of PPI therapy). Additionally,
        chart review of their medical records will be conducted for clinical outcomes. These
        include: - pre-POEM esophageal manometry and pH testing - GERD-HRQL (separate heartburn and
        regurgitation scores) - Eckardt scores - EGD pre-POEM (patients will be assessed for hiatal
        hernia as documented by length, diameter, and Hill grade)
      
Keywords: Per-Oral Endoscopic Myotomy (POEM); Submucosal Endoscopy