HR-EGG in Medically Refractory Gastroparesis
Study Details
Study Description
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:
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Assess for the presence of gastric dysarrythmias in lung transplantation population as compared to alternative etiologies of gastroparesis
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Assess if presence or absence of gastric dysarrythmias is predictive of response or need of Gastric -per-oral endoscopic myotomy
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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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Medically refractory Non-transplanted gastroparesis Etiology of gastroparesis deemed on clinical grounds to NOT be secondary to lung transplantation process ( diabetes, post-surgery, idiopathic, neuromuscular etc.) Gastroparesis defined as > 10% radiotracer remains in the stomach after 4 hour gastric scintigraphy study. Medically refractory is defined as lack of clinical response to trial of diet and lifestyle modifications such as small frequent low fat and low fiber meals and trial or contraindications to prokinetic medications for the treatment of gastroparesis Case Cohort: Assessment of HR-EGG comparing controls (non lung transplant induced gastroparesis) vs lung transplant induced gastroparesis Investigators will further categorize patients into sub- groups based on HR-EGG phenotypes:, such as High Frequency, Low Frequency, High Amplitude, Low Amplitude, Continuous Symptoms, Sensorimotor Symptoms, Mixed Symptoms and Normal on Day. |
Device: High Resolution Electrogastography
a new generation 64- channel high-resolution electrogastrography recording technology by Alimetry Limited that is able to record and analyze body surface gastric mapping/ HR-EGG
Other Names:
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| Medically refractory Post Lung transplant gastroparesis Etiology of gastroparesis deemed on clinical grounds to be secondary to lung transplantation process. Gastroparesis defined as > 10% radiotracer remains in the stomach after 4 hour gastric scintigraphy study. Medically refractory is defined as lack of clinical response to trial of diet and lifestyle modifications such as small frequent low fat and low fiber meals and trial or contraindications to prokinetic medications for the treatment of gastroparesis Case Cohort: Assessment of HR-EGG comparing controls (non lung transplant induced gastroparesis) vs lung transplant induced gastroparesis Investigators will further categorize patients into sub- groups based on HR-EGG phenotypes:, such as High Frequency, Low Frequency, High Amplitude, Low Amplitude, Continuous Symptoms, Sensorimotor Symptoms, Mixed Symptoms and Normal on Day. |
Device: High Resolution Electrogastography
a new generation 64- channel high-resolution electrogastrography recording technology by Alimetry Limited that is able to record and analyze body surface gastric mapping/ HR-EGG
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Assess the presence of gastric dysarrythmias in lung transplantation population compared to alternative etiologies of gastroparesis [2 years]
Investigators will categorize patients into sub- groups based on HR-EGG phenotypes:, such as Low GA-RI, High Frequency, Low Frequency, High Amplitude, Low Amplitude, Continuous Symptoms, Sensorimotor Symptoms, Mixed Symptoms and Normal on Day.
Secondary Outcome Measures
- Sub-type the specific bioelectrical abnormalities to assess which patterns are associated with symptoms and abnormal emptying across all subjects [2 years]
- Assess if presence or absence of gastric dysarrythmias is predictive of response or need of Gastric -per-oral endoscopic myotomy [2 years]
- Assess alterations in gastric dysarrythmias following pyloric interventions including G-POEM [2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Adult patients (age >17 years old) with medically refractory gastroparesis
Exclusion Criteria:
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Females who are pregnant or lactating (self-reported)
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History of skin allergies to skin adhesives or hydrogels
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History of extreme sensitivity to cosmetics or lotions
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Fragile skin vulnerable to skin tears
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Damaged epigastric skin (open wounds, rash, inflammation)
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Patients unable to remain in a relaxed reclined position for the test duration
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BMI > 35 obtained via chart review
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
| 2 | University of Virginia | Charlottesville | Virginia | United States | 22905 |
Sponsors and Collaborators
- University of Virginia
- Baylor College of Medicine
- Stanford University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Agrusa AS, Gharibans AA, Allegra AA, Kunkel DC, Coleman TP. A Deep Convolutional Neural Network Approach to Classify Normal and Abnormal Gastric Slow Wave Initiation From the High Resolution Electrogastrogram. IEEE Trans Biomed Eng. 2020 Mar;67(3):854-867. doi: 10.1109/TBME.2019.2922235. Epub 2019 Jun 12.
- Angeli TR, Cheng LK, Du P, Wang TH, Bernard CE, Vannucchi MG, Faussone-Pellegrini MS, Lahr C, Vather R, Windsor JA, Farrugia G, Abell TL, O'Grady G. Loss of Interstitial Cells of Cajal and Patterns of Gastric Dysrhythmia in Patients With Chronic Unexplained Nausea and Vomiting. Gastroenterology. 2015 Jul;149(1):56-66.e5. doi: 10.1053/j.gastro.2015.04.003. Epub 2015 Apr 8.
- Berry R, Cheng LK, Du P, Paskaranandavadivel N, Angeli TR, Mayne T, Beban G, O'Grady G. Patterns of Abnormal Gastric Pacemaking After Sleeve Gastrectomy Defined by Laparoscopic High-Resolution Electrical Mapping. Obes Surg. 2017 Aug;27(8):1929-1937. doi: 10.1007/s11695-017-2597-6.
- Camilleri M, Parkman HP, Shafi MA, Abell TL, Gerson L; American College of Gastroenterology. Clinical guideline: management of gastroparesis. Am J Gastroenterol. 2013 Jan;108(1):18-37; quiz 38. doi: 10.1038/ajg.2012.373. Epub 2012 Nov 13.
- Du P, Calder S, Angeli TR, Sathar S, Paskaranandavadivel N, O'Grady G, Cheng LK. Progress in Mathematical Modeling of Gastrointestinal Slow Wave Abnormalities. Front Physiol. 2018 Jan 15;8:1136. doi: 10.3389/fphys.2017.01136. eCollection 2017.
- Gharibans AA, Kim S, Kunkel D, Coleman TP. High-Resolution Electrogastrogram: A Novel, Noninvasive Method for Determining Gastric Slow-Wave Direction and Speed. IEEE Trans Biomed Eng. 2017 Apr;64(4):807-815. doi: 10.1109/TBME.2016.2579310. Epub 2016 Jun 9.
- Gharibans AA, Smarr BL, Kunkel DC, Kriegsfeld LJ, Mousa HM, Coleman TP. Artifact Rejection Methodology Enables Continuous, Noninvasive Measurement of Gastric Myoelectric Activity in Ambulatory Subjects. Sci Rep. 2018 Mar 22;8(1):5019. doi: 10.1038/s41598-018-23302-9.
- Hooft N, Smith M, Huang J, Bremner R, Walia R. Gastroparesis is common after lung transplantation and may be ameliorated by botulinum toxin-A injection of the pylorus. J Heart Lung Transplant. 2014 Dec;33(12):1314-6. doi: 10.1016/j.healun.2014.08.016. Epub 2014 Sep 6. No abstract available.
- Nanivadekar AC, Miller DM, Fulton S, Wong L, Ogren J, Chitnis G, McLaughlin B, Zhai S, Fisher LE, Yates BJ, Horn CC. Machine learning prediction of emesis and gastrointestinal state in ferrets. PLoS One. 2019 Oct 18;14(10):e0223279. doi: 10.1371/journal.pone.0223279. eCollection 2019.
- O'Grady G, Angeli TR, Paskaranandavadivel N, Erickson JC, Wells CI, Gharibans AA, Cheng LK, Du P. Methods for High-Resolution Electrical Mapping in the Gastrointestinal Tract. IEEE Rev Biomed Eng. 2019;12:287-302. doi: 10.1109/RBME.2018.2867555. Epub 2018 Aug 29.
- Podboy A, Hwang JH, Nguyen LA, Garcia P, Zikos TA, Kamal A, Triadafilopoulos G, Clarke JO. Gastric per-oral endoscopic myotomy: Current status and future directions. World J Gastroenterol. 2019 Jun 7;25(21):2581-2590. doi: 10.3748/wjg.v25.i21.2581.
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