Background and Aim Gastric emptying scintigraphy (GES) is the reference standard test for diagnosing gastroparesis. Body surface gastric mapping (BSGM) via Gastric Alimetry® is a new test of gastric function that combines non-invasive assessment of gastric electrophysiology and validated symptom profiling. This randomized, prospective pilot study evaluated the impact of GES vs BSGM test results on clinical decision-making.

Methods Patients with chronic gastroduodenal symptoms from a tertiary center referred for GES were recruited. Subjects separately underwent baseline assessment with GES and BSGM testing. Two motility-specialists were first asked to devise a management plan after reviewing a test result (GES or BSGM, in random order). They were then asked to repeat the management plan after reviewing the other test result (BSGM or GES). Clinician-perceived certainty measures were assessed.

Results Sixteen patients, 13 (81%) female, median age 30 years, median BMI 22.5 kg/m2, were recruited. At baseline, a diagnosis was established in 2/16 (12.5%) and increased to 8/16 (50%) with both tests. Abnormal test results were found in 11 patients. In patients with normal results, BSGM symptom profiling phenotyped 5 additional patients. All patients received an intervention following the first unblinding, with subsequent management changes made in 75% (BSGM) and 62.5% (GES) of patients. The combined GES and BSGM results significantly increased diagnostic and management certainty (p<0.05), with both tests having similar influence on management (p>0.05).

Conclusion The combined GES and BSGM test results significantly enhanced diagnostic and management confidence in patients with suspected gastroparesis within a tertiary center.

DF is an independent contractor of Alimetry Ltd. RA and VH declare no conflict of interest.

NCT06411574

This study was supported by the Health Research Council of New Zealand.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Human Research Ethics Committee of Western Sydney University gave ethical approval for this work (H15874).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

ryan.abrahamhealth.nsw.gov.au and d.foongwesternsydney.edu.au

Conflict of interest: DF is an independent contractor of Alimetry Ltd. RA and VH declare no conflict of interest.

Data availability: Data used for analysis will be made available on reasonable request, conditional on ethical approvals.

Funding: This study was supported by the Health Research Council of New Zealand.

Clinical trial registration: NCT06411574.

Data used for analysis will be made available on reasonable request, conditional on ethical approvals.