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Transoral Incisionless Fundoplication in Post-POEM GERD

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ClinicalTrials.gov Identifier: NCT04770441
Recruitment Status : Recruiting
First Posted : February 25, 2021
Last Update Posted : April 30, 2021
Sponsor:
Information provided by (Responsible Party):
Salmaan Azam Jawaid, Baylor College of Medicine

Brief 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


Condition or disease
Swallowing Disorders Achalasia Outlet Obstruction, Gastric Diffuse Esophageal Spasm

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Prospective Evaluation of the Use of TIF (Transoral Incisionless Fundoplication) to Treat Post-poem GERD
Actual Study Start Date : March 17, 2021
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Percentage of patients not requiring PPI therapy at set endpoints [ Time Frame: 1 year ]
    If at least 50% of patients do not require initiation of PPI therapy at the end of the study, then TIF would be considered successful.


Secondary Outcome Measures :
  1. At least 50% of patients with a 50% decrease in GERD-HQRL 3 months post TIF (20) [ Time Frame: 1 year ]
    Assessed and evaluated at protocol's scheduled visits.

  2. Decrease in Demeester scores to less than 14.72 (above this number is consider pathologic acid reflux) in at least 50% of patients [ Time Frame: 1 year ]
    Assessed and evaluated at protocol's scheduled visits.

  3. 50% decrease in the number of patients with percentage of time of acid exposure (pH <4) was less than or equal to 5.3% [ Time Frame: 1 year ]
    Assessed and evaluated at protocol's scheduled visits.

  4. 50% decrease in the number of patients with percentage time pH <4 reduced to 30% of the pre-TIF value (21) [ Time Frame: 1 year ]
    Assessed and evaluated at protocol's scheduled visits.

  5. 50% improvement in esophageal GERD related [ Time Frame: 1 year ]
    Assessed and evaluated at protocol's scheduled visits.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

Inclusion Criteria:

  • Age greater than 18 years old
  • Able to sign consent
  • Patients must meet standard clinical indications for POEM procedure (all indications) for the initial enrollment
  • To undergo TIF: Evidence of GERD/GERD related complications after POEM:
  • pathologic acid exposure on pH testing (Deemester score >14.72 or percentage time pH <4 greater than 5.3%) off of PPI (19)
  • esophagitis on EGD (grades A to C)
  • biopsies showing evidence of reflux esophagitis

Exclusion Criteria:

  • Adults unable to consent
  • Pregnant women - Prisoners
  • Delayed gastric emptying
  • Code status of DNR/DNI or CMO
  • Any patient with moderate to severe esophagitis pre-POEM
  • Grade D esophagitis post POEM
  • Hiatal hernia >2cm
  • PPI use prior to POEM (and if PPI is needed)
  • Previous surgery of the stomach
  • Known GI malignancy
  • Cirrhosis with portal hypertension, varices, or ascites
  • Previous anti-reflux surgery
  • Patients who choose not to undergo TIF or if insurance will not cover the procedure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04770441


Contacts
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Contact: Michael Mercado 7137983606 Michael.Mercado@bcm.edu
Contact: Salmaan Jawaid, MD 713-798-0950 Salmaan.Jawaid@bcm.edu

Locations
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United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Michael Mercado    713-798-3606    Michael.Mercado@bcm.edu   
Contact: Salmaan Jawaid, MD    713-798-0950    Salmaan.Jawaid@bcm.edu   
Principal Investigator: Salmaan Jawaid, MD         
Sub-Investigator: Mohamed Othman, MD         
Sub-Investigator: Kalpesh Patel, MD         
Sponsors and Collaborators
Baylor College of Medicine
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Responsible Party: Salmaan Azam Jawaid, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04770441    
Other Study ID Numbers: H-48496
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is a single-site prospective study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Salmaan Azam Jawaid, Baylor College of Medicine:
Per-Oral Endoscopic Myotomy (POEM)
Submucosal Endoscopy
Additional relevant MeSH terms:
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Deglutition Disorders
Esophageal Spasm, Diffuse
Esophageal Motility Disorders
Gastric Outlet Obstruction
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Stomach Diseases