Gastroparesis
Conditions
Keywords
Gastroparesis, Motility Disorders, Gastric Emptying Scintigraphy, Body Surface Gastric Mapping
Brief summary
Gastroparesis is a chronic and debilitating gastric disease associated with poor quality of life, psychological distress, frequent hospitalisations, and high healthcare utilization and associated costs. It is defined by persistent upper gastrointestinal symptoms and delayed gastric emptying with no mechanical gastric outlet obstruction. Gastric emptying scintigraphy (GES) is the current gold standard for diagnosing gastroparesis but its clinical utility is currently being questioned. Current management strategies have often been found to be ineffective, largely due to an incomplete understanding of the disease's pathophysiology. There is a critical need for more advanced diagnostic testing that can better diagnose patients and guide personalized targeted therapy. Body surface gastric mapping (BSGM) using Gastric Alimetry (Alimetry Ltd., New Zealand) is a new FDA-cleared medical device to assess gastric function by non-invasively assessing gastric motility using simultaneous high-resolution electrogastrography and symptom profiling. BSGM has demonstrated clinical utility in the assessment of gastric function through patient phenotyping in a variety of cohorts, including patients with nausea and vomiting disorders, diabetes, delayed gastric emptying, and post-gastric surgery. Previous research revealed that the detection of gastric motility abnormality rates through patient phenotyping were higher using Gastric Alimetry compared to GES (43% vs 23%). Clinical application of these phenotypes has also aided in changing management decisions, which reduced healthcare utilization and associated costs. However, how GES and BSGM test results differentially influence clinical management in patients is uncertain. This exploratory pilot study proposes a two-arm, prospective trial to assess whether BSGM-guided care could change clinical outcomes compared to the standard of care (GES) in patients with suspected gastroparesis. The trial consists of two phases. Phase 1 involves participants separately undertaking a GES and BSGM test. Based on these results, the referring clinician will devise management plans for treatment using a standardized form: 1) unblinded to one test (GES or BSGM) but blinded to the other test; and 2) unblinded to both tests (GES + BSGM). They will be asked to recommend any changes to interventions (medications, diet, endoscopic/surgical referral or other) and additional testing. In phase 2, those in Phase 1 will undergo BSGM-guided care based on their combined management plan (GES + BSGM) and followed up over a 12 month period. A separate set of participants will be recruited to undergo standard of care (GES only) in parallel with Phase 1 participants. After 12 months, those on the standard of care arm will be crossed over to BSGM-guided care, undergo a BSGM test, treated according to the new management plan, and followed up over 6 months. Questionnaires will assess symptoms, quality of life, health psychology, sleep, and work impact. If validated, this may change clinical practice by reducing the need for invasive or radioactive-based procedures to diagnose these patients and facilitating a more targeted treatment approach.
Interventions
DEVICEGastric Alimetry
The Gastric Alimetry™ System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders.
Sponsors
University of Western Sydney
University of Auckland, New Zealand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Participants will be recruited into one of two groups: standard of care (GES only) or BSGM-guided care (GES + BSGM). Each group will undergo treatment based on their respective management plan.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged over 18 years old * Meeting Rome IV Criteria for Functional Dyspepsia and/or Chronic Nausea and Vomiting Syndrome * Referred for gastric emptying scintigraphy * Normal gastroscopy * Negative or treated H. Pylori status
Exclusion criteria
* Pregnant or breast-feeding * Inability to perform a BSGM test according to Indications for Use: history of severe skin allergies or sensitivity to cosmetics or lotions; chronically damaged or vulnerable epigastric skin (fragile skin, wounds, inflammation); unable to remain in a relaxed reclined position for the test duration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Change in Clinical Management Decisions Based on the Combined Test Results Compared to the Single Test Result. | After unblinding to first test (week 1) and after unblinding to second test (week 2) | In phase 1, the change in clinical management decisions from the single test result to the combined test results was assessed. For each arm, the proportion of patients with a management change is reported as a percentage. In the first plan (either unblinded to BSGM or GES first), a management change was defined as any addition, removal or modification within a category (eg, switching from 1 prokinetic to another) compared to the initial management plan. In the second plan (unblinded to both test results), a change due to the combined test results was defined as any addition, removal or modification within the same category compared to the first plan. The categories were: medication, diet, psychology-based interventions, surgery referral, other intervention and additional testing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Change to a Single Clinical Diagnosis Due to the Combined Test Results From Baseline. | After unblinding to first test (week 1) and after unblinding to second test (week 2) | In phase 1, a change in diagnosis was defined as either an addition of a diagnosis or a shift to a different one compared to baseline (confirmation of an existing diagnosis was not considered a change). |
| Phase 1: Change in Clinician Certainty Based on the Combined Test Results Compared to a Single Test Result | After unblinding to first test (week 1) and after unblinding to second test (week 2) | In phase 1, Clinicians rated diagnostic and management plan certainty using a Likert scale (0-10; 0 = uncertain, 10 = certain) firstly after reviewing the initial allocated test (GES or BSGM) and formulating the first management plan with a single test result, and again after reviewing the second test and formulating the second management plan with the combined test results. The change in the certainty score from the single test result to the combined test results was assessed. |
Countries
Australia
Contacts
PRINCIPAL_INVESTIGATORVincent Ho, MBBS, FRACP, FACP, PhD
Western Sydney University
Participant flow
Recruitment details
Patients aged ≥ 18 years old and referred to GES for evaluation of their chronic gastroduodenal symptoms were recruited from a tertiary center.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 30 Years |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 16 | 0 / 0 |
| other Total, other adverse events | 0 / 8 | 0 / 8 | 0 / 16 | 0 / 0 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 16 | 0 / 0 |
Outcome results
None listed