Gastroparesis
Conditions
Keywords
endoscopy, electrophysiology, phenotyping
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTGastric Alimetry 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.
Sponsors
Chris Varghese
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older * Indicated for GPOEM
Exclusion criteria
* Pregnant or breast-feeding * Inability to perform Gastric Alimetry test: history of severe skin allergies or sensitivity to cosmetics or lotions; chronically damaged or vulnerable epigastric skin (fragile skin, wounds, inflammation); patients unable to remain in a relaxed reclined position for the test duration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastroparesis Cardinal Symptom Index (GCSI) | 6 months | ≥ 1 decrease in total GCSI score \[higher score = worse symptoms\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire - 8 (PHQ-8) | 6, and 12 months | 0 - 12; higher score being increased depression severity |
| Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life (PAGI-QoL) | 1, 3, 6, and 12 months | 0 - 5; higher score = better quality of life |
| EQ-5D scores | 1, 3, 6, and 12 months | 0 - 1; higher score being better quality of life |
| Patient assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM) | 1, 3, 6, and 12 months | 0 - 1; higher score being increased symptom burden |
| Perceived Stress Scale 4 (PSS-4) | 6, and 12 months | 0 - 16; higher scores indicate higher stress |
| Brief Illness Perception Questionnaire-Revised | 6, and 12 months | 0 - 80; higher scores indicate worse illness perception |
| Alimetry® Gut-Brain Wellbeing (AGBW) | 1, 3, 6, and 12 months | 0 - 40; higher scores indicate higher mental health burden |
| Work Productivity and Activity Impairment (WPAI) | 12 months | 0-100%; higher scores indicating increased loss of work productivity and activity impairment |
| Generalized Anxiety Disorder 7-item (GAD-7) | 6, and 12 months | 0 - 21; higher score indicates increased anxiety |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Gastric Alimetry Phenotype | 6 | Change in phenotype classification on repeat Gastric Alimetry testing before and after G-POEM |
Countries
New Zealand
Contacts
Primary ContactChris Varghese, MBChB
Outcome results
None listed