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Transoral Incisionless Fundoplication in Post-POEM GERD

Sponsored by Baylor College of Medicine

About this trial

Last updated 2 years ago

Study ID

H-48496

Status

Completed

Type

Observational [Patient Registry]

Placebo

No

Accepting

18-75 Years
18 to 64 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 years ago

What is this trial about?

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

What are the participation requirements?

Yes

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

No

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.

Locations

Location

Status