Predicting Outcomes of Gastric Peroral Endoscopic Myotomy Using a Gastric Electrical Mapping System: GPOEM-GEMS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Gastroparesis Cardinal Symptom Index (GCSI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 18 years or older
- •Indicated for GPOEM
排除标准
- •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.
结局指标
主要结局
Gastroparesis Cardinal Symptom Index (GCSI)
时间窗: 6 months
≥ 1 decrease in total GCSI score \[higher score = worse symptoms\]
次要结局
- Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life (PAGI-QoL)(1, 3, 6, and 12 months)
- Patient Health Questionnaire - 8 (PHQ-8)(6, and 12 months)
- Work Productivity and Activity Impairment (WPAI)(12 months)
- Generalized Anxiety Disorder 7-item (GAD-7)(6, and 12 months)
- Perceived Stress Scale 4 (PSS-4)(6, and 12 months)
- EQ-5D scores(1, 3, 6, and 12 months)
- Patient assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM)(1, 3, 6, and 12 months)
- Brief Illness Perception Questionnaire-Revised(6, and 12 months)
- Alimetry® Gut-Brain Wellbeing (AGBW)(1, 3, 6, and 12 months)
研究者
Chris Varghese
Lead Clinical Investigator
University of Auckland, New Zealand