Comparing the Impact of Body Surface Gastric Mapping and Gastric Emptying Scintigraphy on Clinical Management in Suspected Gastroparesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in clinical management decisions based on the combined test results.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
BSGM-guided care
Both the GES and BSGM test results will be used to guide treatment.
干预措施: Gastric Alimetry (Device)
Standard of care
Only the GES test result will be used to guide treatment as part of standard of care.
结局指标
主要结局
Change in clinical management decisions based on the combined test results.
时间窗: Baseline
A change constitutes any change within a category (e.g. from a prokinetic to neuromodulator, from one prokinetic to another), addition of category or removal of category. If the plan remains the same, this is considered no change.
Healthcare utilization-associated costs (expressed as the total amount in AUD) between standard of care and BSGM-guided care.
时间窗: 12 months.
Costs associated with healthcare events (emergency department visits, hospital admissions, gastroenterology clinic visits and investigations) before and after testing.
Healthcare utilization (expressed as work impairment percentages; higher scores meaning worse outcome) between standard of care and BSGM-guided care.
时间窗: 12 months.
Work impairment scale is Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (minimum: 0; maximum: 100).
Phase 1: Change in Clinical Management Decisions Based on the Combined Test Results Compared to the Single Test Result.
时间窗: 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.
次要结局
- Change in 5-level EQ-5D (minimum: 0; maximum: 1) scores between standard of care and BSGM-guided care (with a lower score meaning worse outcome).(12 months.)
- Change in Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life (minimum: 0; maximum: 5) scores between standard of care and BSGM-guided care (with a lower score meaning worse outcome).(12 months.)
- Change in General Anxiety Disorder-7 (minimum: 0; maximum: 21) scores between standard of care and BSGM-guided care (with a higher score meaning worse outcome).(12 months.)
- Change in Perceived Stress Scale-4 (minimum: 0; maximum: 4) scores between standard of care and BSGM-guided care (with a higher score meaning worse outcome).(12 months.)
- Change in Gastroparesis Cardinal Symptom Index (minimum: 0; maximum: 5) scores between standard of care and BSGM-guided care (with a higher score meaning worse outcome).(12 months.)
- Change in Patient Assessment of Upper Gastrointestinal Symptom Severity Index (minimum: 0; maximum: 5) scores between standard of care and BSGM-guided care (with a higher score meaning worse outcome).(12 months.)
- Change in clinical management decisions based on order of unblinding motility test results (GES then BSGM vs BSGM then GES).(Baseline)
- Change in Patient Health Questionnaire-8 (minimum: 0; maximum: 24) scores between standard of care and BSGM-guided care (with a higher score meaning worse outcome).(12 months.)
- 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))
- 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))
研究者
Vincent Ho
Associate Professor
University of Western Sydney