NCT07526935进行中（未招募）不适用
Combined Role of Gastric Peroral Endoscopic Myotomy and Gastric Electrical Stimulator in the Management of Refractory Gastroparesis- A Randomized Single Blinded Control Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Gastroparesis Symptoms Changes
研究概览
简要总结
This study is looking at how safe and effective G-POEM, GES and a combination of both are for people with severe stomach problems (gastroparesis) that haven't gotten better with medicine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Adult patients of age 18 years and older
- •Patients must be able to consent
- •Documented diagnosis of refractory GP as determined by the following criteria:
- •Medically refractory GP symptoms for > 1 year despite treatment with first-line modalities and pharmacotherapies with anti-emetics and prokinetics AND
- •Gastric emptying scintigraphy showing delayed gastric emptying with retention of >60% at 2h and/or greater than 10% at 4h based on standardized radionuclide solid meal test
- •Preoperative Gastroparesis Cardinal Symptom Index (GCSI) Score
- •Aecision to treat patient with surgical therapy of G-POEM and/or electric stimulator
排除标准
- •Patients with prior surgical intervention for gastroparesis
- •Patients less than 18 years old
- •Pregnant women
研究组 & 干预措施
G-POEM only
Active Comparator
GES off + GPOEM
干预措施: G-POEM only (Procedure)
Control group
Active Comparator
GES off + Upper Endoscopy
干预措施: Standard of Care (Other)
GES only
Active Comparator
GES on + Upper Endoscopy
干预措施: Group 1 (Device)
Combination G-POEM and GES
Active Comparator
GES on + GPOEM
干预措施: Group 2 (Device)
结局指标
主要结局
Gastroparesis Symptoms Changes
时间窗: Baseline, Preoperative 3 months, 6 months, 9 months, 12 months
Monitoring changes in gastroparesis symptom severity as measured by the Gastroparesis Cardinal Symptom Index (GCSI).
次要结局
- Subjects quality of life(Baseline, 6 months, 12 months.)
- Weight(Baseline, 6 months, 12 months)
- BMI(Baseline, 6 months, 12 months)
- Nurtritional Support Status(Baseline, 6 months, 12 months)
- Gastroparesis-related hospitalizations(12 month follow-up)
- ED visits for symptoms(12 month follow-up)
- Gastric Emptying(Baseline, 6 months, 12 months)
- Antiemetic/Prokinetic use(Baseline, 6 months, 12 months)
研究者
研究点 (1)
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