Clinical trial NCT05789511: HR-EGG in Medically Refractory Gastroparesis
Official title: High Resolution Electrogastrography (HR-EGG) Assessment in Medically Refractory Gastroparesis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastroparesis
Lung Transplant; Complications
Keywords: Gastroparesis
Post- Lung Transplant
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Baylor College of Medicine
name: Stanford University
First posted: 2023-03-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lung Transplant induced gastroparesis body surface gastric mapping via the HR-EGG will be compared to non-lung transplant induced gastroparesis patients

Brief summary: The goal of this observational study is to utilize a novel high resolution electrogastrography device to gauge if identification of gastric dysarrythmias can reliably identify patients that will respond to or will require definitive pyloric interventions such as a G-POEM procedure in patients with medically refractory gastroparesis

Aims:

1. Assess for the presence of gastric dysarrythmias in lung transplantation population as compared to alternative etiologies of gastroparesis
2. Assess if presence or absence of gastric dysarrythmias is predictive of response or need of Gastric -per-oral endoscopic myotomy
3. Assess alterations in gastric dysarrthmias following pyloric interventions including G-POEM.

Patients will undergo two surface body surface gastric mapping via the HR-EGG before and after undergoing a gastric per oral endoscopic myotomy as standard clinical care for the treatment of medically refractory gastroparesis

Detailed description: Gastroparesis is a chronic digestive disorder defined by the symptoms of nausea, vomiting, bloating, and abdominal pain in the setting of objectively delayed gastric emptying without mechanical gastric outlet obstruction. Gastroparesis is frequently identified after lung transplantation with incidence rates as high as 44%. Gastroparesis after lung transplantation is of significant concern as complications directly related to gastroparesis, specifically gastroesophageal reflux and aspiration, have been linked to the development of bronchiolitis obliterans syndrome, the primary cause of graft failure and the main cause of late morbidity and mortality following lung transplantation. Effective long-term therapy for medically refractory post-lung transplant gastroparesis represents a significant therapeutic challenge. Current therapies (such as botulinum toxin injection or surgical pyloromyotomy/bypass) are either limited by inconsistent efficacy or by their invasiveness. However, recent advances in endoscopic tunneling techniques have led to the development of gastric per-oral endoscopic myotomy (G-POEM). Initial reports of this technique for treatment of post-lung transplant gastroparesis are encouraging, with excellent preliminary safety and efficacy data. However, currently there are no clinical, endoscopic, or radiographic parameters that reliably predict which patients will respond to G-POEM. This is likely secondary to the multifactorial pathophysiology of gastroparesis. Secondary to this there is an unmet need to develop a widely deployable screening tool that is i) non-invasive, ii) able to reliably divide gastroparesis into pathophysiologic subgroups and iii) be able to guide effective treatments.

In a similar fashion to that of the brain and heart, waves generated at the stomach's surface propagate to the skin via volume conduction. These voltages can be measured with cutaneous electrodes, via gastric electrophysiology (EGG) noninvasively. However, the EGG has not encountered widespread clinical adoption as the ability to both reliably and consistently differentiate gastrocutaneous spatial dysrhythmias has not been possible. However, a novel 'high-resolution EGG' (HR-EGG), a multi-electrode array of 25 or more electrodes, has been shown to capture slow waves with high spatial resolution and extract meaningful spatial (as opposed to spectral) features, including the instantaneous slow wave direction at any given point in space. This coupled with novel deep convolutional neural network (CNN) frameworks and artifact rejection methods, have been able to reliably capture gastric myoelectricspatial abnormalities that correlate with symptom incidence and severity in gastroparesis patients.

Currently, a new generation of high-resolution electrogastrograms recording technology with 64-channel electrode array is being developed by Alimetry Limited that is able to provide body surface gastric mapping (BSGM). This BSGM is able to provide a more complete understanding of the origin and propagation of human gastric slow-wave activity non-invasively, such as frequency and pattern, in high spatiotemporal detail. The system also includes an App for tracking patient-reported symptoms throughout the test.

Our goal is to utilize this proprietary device to gauge if identification of gastric dysarrythmias can reliably identify patients that will respond to or will require definitive pyloric interventions such as a G-POEM procedure.

Eligibility criteria: Inclusion Criteria:

* Adult patients (age \>17 years old) with medically refractory gastroparesis

Exclusion Criteria:

* Females who are pregnant or lactating (self-reported)
* History of skin allergies to skin adhesives or hydrogels
* History of extreme sensitivity to cosmetics or lotions
* Fragile skin vulnerable to skin tears
* Damaged epigastric skin (open wounds, rash, inflammation)
* Patients unable to remain in a relaxed reclined position for the test duration
* BMI \> 35 obtained via chart review

Primary outcomes:
measure: Assess the presence of gastric dysarrythmias in lung transplantation population compared to alternative etiologies of gastroparesis
timeFrame: 2 years
Secondary outcomes:
measure: Sub-type the specific bioelectrical abnormalities to assess which patterns are associated with symptoms and abnormal emptying across all subjects
timeFrame: 2 years
measure: Assess if presence or absence of gastric dysarrythmias is predictive of response or need of Gastric -per-oral endoscopic myotomy
timeFrame: 2 years
measure: Assess alterations in gastric dysarrythmias following pyloric interventions including G-POEM
timeFrame: 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References:
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