A Randomized, Sham-controlled Trial: Endoscopic Myotomy of the Pylorus To Improve Emptying and Symptoms (EMPTIES)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Gastroparesis Cardinal Symptom Index (GCSI)
研究概览
简要总结
A randomized clinical trial comparing endoscopic per-oral pyloromyotomy (POP) versus a control sham intervention (diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption) in patients with medically refractory gastroparesis.
详细描述
A comparative effectiveness, single center (with two surgical units), randomized (1:1) study of endoscopic per-oral pyloromyotomy (POP) versus a control sham intervention (diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption) in adult patients with medically refractory gastroparesis who have failed management with dietary, lifestyle, and pharmacological therapy for at least six months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18-75
- •Diagnosis of medically refractory gastroparesis by 4 hour non-extrapolated solid phase gastric emptying study completed within 12 months of enrollment. Medical refractoriness is defined by at least 6 months of medical treatment with no significant improvement in baseline symptoms
- •Completion of all routine assessments in our multidisciplinary gastroparesis clinic, which includes evaluation by gastroenterology, behavioral health, and nutrition specialists
- •Ability to take oral medication and be willing to adhere to the post-procedure dietary and medication regimen
- •For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Willingness and reasonable expectation that the individual will be able to travel to the study site for the intervention and each scheduled in-person assessment, as well as virtual assessments if necessary
- •Be able to speak and read the English language.
排除标准
- •Active use of narcotic pain medication
- •Presence of concomitant gastrointestinal transit disorder such as small bowel dysmotility or uncontrolled colonic dysmotility (As defined by clinical judgement or < 3 bowel movements per week)
- •Etiology of gastroparesis is post-surgical
- •Pregnancy or lactation
- •History of egg allergy
- •Prior surgical intervention of the stomach or gastric pylorus
- •Current parenteral nutrition
- •Uncontrolled coagulopathy (platelet count <50,000 and INR>1.5) or use of anticoagulant medications (with the exception of antiplatelet therapy)
研究组 & 干预措施
Endoscopic per-oral pyloromyotomy (POP)
Participants will undergo Endoscopic per-oral pyloromyotomy (POP).
干预措施: Endoscopic per-oral pyloromyotomy (POP) (Procedure)
Sham / Control Arm
Participants will undergo a diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption. Following the 12-week blinded trial period, these participants will be unblinded and offered Endoscopic per-oral pyloromyotomy (POP) if they remain symptomatic.
干预措施: Endoscopic per-oral pyloromyotomy (POP) (Procedure)
Sham / Control Arm
Participants will undergo a diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption. Following the 12-week blinded trial period, these participants will be unblinded and offered Endoscopic per-oral pyloromyotomy (POP) if they remain symptomatic.
干预措施: Diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption (Procedure)
结局指标
主要结局
Gastroparesis Cardinal Symptom Index (GCSI)
时间窗: Baseline, 12 weeks post-procedure
Change in Gastroparesis Cardinal Symptom Index (GCSI) at Baseline to 12 weeks post-procedure. Possible scores range from 0 (None) to 5 (Very Severe).
次要结局
- Gastric Emptying(Baseline, 12 weeks post-procedure)
- 36-Item Short Form; Quality of Life Survey(Baseline,12 weeks post-procedure)
研究者
Matthew Allemang
Principal Investigator
The Cleveland Clinic