Transoral Incisionless Fundoplication in Post-POEM GERD

NCT04770441 | Completed

• 1 other identifier: H-48496
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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

Conditions

Swallowing Disorders; Achalasia; Outlet Obstruction, Gastric; Diffuse Esophageal Spasm

Keywords

Per-Oral Endoscopic Myotomy (POEM); Submucosal Endoscopy

Outcome Measures

Primary Outcomes (1)

• Percentage of patients not requiring PPI therapy at set endpoints

  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.

  1 year

Secondary Outcomes (5)

• At least 50% of patients with a 50% decrease in GERD-HQRL 3 months post TIF (20)

  1 year

• Decrease in Demeester scores to less than 14.72 (above this number is consider pathologic acid reflux) in at least 50% of patients

  1 year

• 50% decrease in the number of patients with percentage of time of acid exposure (pH <4) was less than or equal to 5.3%

  1 year

• 50% decrease in the number of patients with percentage time pH <4 reduced to 30% of the pre-TIF value (21)

  1 year

• 50% improvement in esophageal GERD related

  1 year

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Deglutition Disorders; Esophageal Achalasia; Gastric Outlet Obstruction; Esophageal Spasm, Diffuse

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Motility Disorders; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 25, 2021
• Study Start: March 17, 2021
• Primary Completion: October 15, 2022
• Study Completion: June 3, 2023
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)