Status:
COMPLETED
Transoral Incisionless Fundoplication in Post-POEM GERD
Lead Sponsor:
Baylor College of Medicine
Conditions:
Swallowing Disorders
Achalasia
Eligibility:
All Genders
18-64 years
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 pro...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 17 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 3 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04770441
Start Date
March 17 2021
End Date
June 3 2023
Last Update
August 18 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Baylor College of Medicine
Houston, Texas, United States, 77030