The aim of this protocol is to build on the investigators currently approved study to
evaluate the outcomes and predictors of success of Gastric peroral endoscopic myotomy
(G-POEM). The investigators plan to incorporate BSGM in determining the treatment success
after G-POEM in patients with refractory gastroparesis and potentially identify a
phenotype of gastroparesis patients who may respond more favorably to G-POEM based on
their baseline BSGM profile. The currently approved G-POEM study (IRB #1708840627 and
ClinicalTrials.gov ID NCT04434781) at our center tracks patients' symptoms and quality of
life at baseline and post G-POEM. the investigators plan to supplement the existing study
by adding BSGM variables. Although the investigators have specific outcomes identified,
the investigators would like to stress that this is a pilot study that will serve to
identify patterns and trends that could be studied further in the future using larger
cohorts of patients.
The investigators' primary objective is to evaluate the safety and feasibility BSGM in
refractory gastroparesis patients undergoing G-POEM.
the investigators will also investigate whether changes in BSGM measures correlate with
changes in symptoms and quality of life.
Additionally, the investigators' aim to compare the diagnostic performance of BSGM, and
gastric emptying scans as depicted on scintigraphy.
The investigators' primary aim is to assess the feasibility and safety of in
gastroparesis patients undergoing G-POEM. Clinical success is defined as improvement in
GCSI by 1 point or more compared to baseline.
The investigators will report four spectral metrics, each profiling distinct features of
gastric function:
Body Surface Gastric Mapping Rhythm IndexTM (GA-RI) - a measure of gastric rhythm
stability.
Principal Gastric Frequency - the frequency associated with stable, persistent
gastric activity as defined by GA-RI.
BMI-adjusted amplitude.
Fed: Fasted Amplitude Ratio (ff-AR).
Although not directly related to this outcome, the investigators will continue our
symptom analysis (as has been previously done under the existing G-POEM protocol) that
includes both the pattern and severity of individual symptoms, such as vomiting, reflux,
and belching. The investigators will continue to assess patient quality of life using
standardized questionnaires (SF-36) at baseline and 3 months post-G-POEM as is currently
done with the existing protocol.
This is an addition to an existing study protocol. The study will involve patients with
refractory gastroparesis (proven on a 4-hour solid-phase gastric emptying scan, along
with limited or no response (or intolerance) to at least 3 months of lifestyle
adjustments, dietary modifications, and medications) who will undergo G-POEM. BSGM will
be used to assess gastric motility before and after the procedure. This design allows for
the collection of data at multiple time points to assess changes in BSGM phenotypes,
gastroparesis symptoms, and other relevant variables over time.
The study team will enroll 20 participants who will undergo BSGM at baseline prior to
G-POEM procedure and then again 3-6 months after G-POEM. The study team plan to contact
participants prior to their standard of care clinic visit to ensure participants meet
eligibility criteria. The study team will also explain the study over the phone using the
telephone script that has been approved (Appendix 1). If they are interested in the
study, the study team will schedule them for BSGM and go over prep instructions. Once the
participant arrives in clinic, teh study team will consent in-person.