Body Surface Gastric Mapping vs Gastric Emptying Scintigraphy on Clinical Management in Gastroparesis - Trial NCT06411574

Timeline & Enrollment

Primary Outcome

Change in clinical management decisions based on the combined test results.,Healthcare utilization (expressed as work impairment percentages; higher scores meaning worse outcome) between standard of care and BSGM-guided care.,Healthcare utilization-associated costs (expressed as the total amount in AUD) between standard of care and BSGM-guided care.

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.

ICD-10 Classifications