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Gastric peroral endoscopic myotomy (GPOEM) is a minimally-invasive procedure that involves dividing the pylorus, to enhance gastric emptying in gastroparesis patients. This is a single-arm, multi-centre, prospective observational study to determine the clinical utility of Gastric Alimetry in predicting GPOEM treatment outcomes. The investigators further aim to develop a clinical decision rule to inform patient selection. Gastric Alimetry will be conducted <1 month prior to GPOEM. All subjects will then be followed up for 12 months.
This protocol proposes no change to the clinical management of patients which is left to the discretion of the patients' primary clinical team.
Patients as part of this study will undergo a baseline assessment via Gastric Alimetry, and concurrent symptom, quality of life, and health psychology questions.
GPOEM will be performed as per standard site protocol, with data captured in RDCap.
Patients will be followed up at 1-month, 3-month, 6-months, and 12-months using the myCap (REDCap) app.
Participants and clinicians can opt-in for a repeat Gastric Alimetry test at 6 or 12 months following their GPOEM procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients with gastroparesis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastric Alimetry test | Diagnostic Test | Gastric Alimetry test will be performed within 30-days prior to G-POEM procedure. It's results will not inform clinical management in this observational study. |
| Measure | Description | Time Frame |
|---|---|---|
| Gastroparesis Cardinal Symptom Index (GCSI) | ≥ 1 decrease in total GCSI score [higher score = worse symptoms] | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life (PAGI-QoL) | 0 - 5; higher score = better quality of life | 1, 3, 6, and 12 months |
| EQ-5D scores | 0 - 1; higher score being better quality of life |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gastric Alimetry Phenotype | Change in phenotype classification on repeat Gastric Alimetry testing before and after G-POEM | 6 |
Inclusion Criteria:
Exclusion Criteria:
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Adult patients aged 18-years or older with gastroparesis awaiting a G-POEM procedure that are able to undergo Gastric Alimetry testing.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chris Varghese, MBChB | Contact | +64 (0) 9 923 9820 | cvar706@aucklanduni.ac.nz |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Auckland | Recruiting | Auckland | Auckland | 1010 | New Zealand |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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| 1, 3, 6, and 12 months |
| Patient assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM) | 0 - 1; higher score being increased symptom burden | 1, 3, 6, and 12 months |
| Patient Health Questionnaire - 8 (PHQ-8) | 0 - 12; higher score being increased depression severity | 6, and 12 months |
| Generalized Anxiety Disorder 7-item (GAD-7) | 0 - 21; higher score indicates increased anxiety | 6, and 12 months |
| Perceived Stress Scale 4 (PSS-4) | 0 - 16; higher scores indicate higher stress | 6, and 12 months |
| Brief Illness Perception Questionnaire-Revised | 0 - 80; higher scores indicate worse illness perception | 6, and 12 months |
| Alimetry® Gut-Brain Wellbeing (AGBW) | 0 - 40; higher scores indicate higher mental health burden | 1, 3, 6, and 12 months |
| Work Productivity and Activity Impairment (WPAI) | 0-100%; higher scores indicating increased loss of work productivity and activity impairment | 12 months |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |