Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04770441 |
| Other study ID # |
H-48496 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 17, 2021 |
| Est. completion date |
June 3, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Baylor College of Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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
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.
