A Pilot and Feasibility Trial of G-POEM for Gastroparesis to Assess Safety, Physiological Mechanisms and Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 3
- 试验地点
- 4
- 主要终点
- GCSI-DD change
研究概览
简要总结
The purpose of this research is to evaluate the 12-month treatment effect of peroral endoscopic pyloromyotomy (G-POEM) vs. sham surgery in patients with gastroparesis that is not helped by medications and to analyze factors that may predict the outcome of the surgery.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms of chronic nausea or vomiting compatible with gastroparesis (idiopathic or diabetic) must be present for at least one year (does not have to be contiguous) prior to registration.
- •Must have a mean total Gastroparesis Cardinal Symptom Index (GCSI) score of ≥ 3 at screening visit.
- •Refractory gastroparesis, defined using our previously published data5, as a failure to improve over the last 6 months, despite an adequate trial of one or more standard prokinetics (metoclopramide, erythromycin, prucalopride), antinauseants (5-HT3 antagonists, promethazine, prochlorperazine, dronabinol), or neuromodulators (mirtazapine, buspirone).
- •Moderate to severe delay in gastric emptying, defined as > 25% solid retained at 4 hours or > 75% retained at 2 hours. The qualifying gastric emptying scintigraphy must be performed within 18 months prior to registration or can be the baseline gastric emptying.
- •No evidence of mechanical obstruction based on upper GI endoscopy or upper GI series in their medical history.
排除标准
- •Another active disorder which could explain symptoms in the opinion of the investigator.
- •Gastric retention of solids at 4 hours < 25% or < 75% at 2 hours.
- •Ongoing use of prokinetic agents (e.g., metoclopramide, erythromycin, prucalopride) GLP -1 analog or agonists, or drugs that slow down gastric emptying (narcotics). Neuromodulators such as tricyclic antidepressants (amitriptyline or nortriptyline) or others that are being used at stable doses for a month prior to randomization may continue at the discretion of the care provider.
- •Significant systemic illness such as chronic renal failure (adjusted for age) or liver disease as defined by Child-Pugh score of 10 or greater.
- •Poorly controlled diabetes with HbA1c of greater than 10% at time of screening.
- •New medications for gastroparesis-related symptoms started within 1 month prior to registration.
- •Pregnancy or nursing.
- •Failure to give informed consent.
- •Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study.
- •Botox injection into the pylorus within 3 months prior to registration.
- •Allergy to eggs or Egg Beaters and Ensure.
研究组 & 干预措施
G-POEM
干预措施: Gastric peroral endoscopic myotomy. (Procedure)
Sham procedure
干预措施: Sham Gastric peroral endoscopic myotomy. (Procedure)
结局指标
主要结局
GCSI-DD change
时间窗: Baseline to 48 weeks post treatment
The effect of GPOEM on nausea, early satiety, postprandial fullness, and upper abdominal pain as per changes in patient scoring in The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) which has been designed to assess symptoms associated with gastroparesis. Symptoms are rated as none (0), mild (1), moderate (2), severe (3), very severe (4) scale of the worst severity of the symptom over the last 24 hours.
次要结局
- Change in Quality of Life as assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life scale(Baseline to 48 weeks post treatment)
研究者
Michael Camilleri, MD
Principal Investigator
Mayo Clinic