Feasibility of Endoscopic Pylorotomy in the Treatment of Refractory Gastroparesis, Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of technical success for endoscopic pylorotomy on the total number of gestures.
研究概览
简要总结
Gastroparesis is a common chronic condition, disabling the limited therapeutic resources justifying the exploration of new therapeutic possibilities.
By analogy to the technique of Per Oral Endoscopic Myotomy (POEM), we believe that myotomy pyloric muscle (POP = Per Oral Pyloromyotomy) endoscopically could become a treatment of choice in the refractory gastroparesis with drug treatments by attacking the pyloric obstacle often spastic that counteracts an effective gastric emptying.
详细描述
Experimental study, prospective, single-center, POP feasibility pilot in the treatment of refractory gastroparesis.
Patients with gastroparesis (significant prolongation of gastric emptying) unimproved by prokinetic treatment and meet all the eligibility criteria will be included after a period of reflection of two weeks minimum.
20 patients will be prospectively included 10 patients with diabetic gastroparesis, 10 patients with non-diabetic gastroparesis (post-surgical, post-Sjogren, idiopathic).
POP will be performed under general anesthesia in intubated-ventilated patients using a carbon dioxide (CO2) inflator. The published standard technique and learned by our team on the pig model will be conducted: submucosal tunnel at the anterior surface of the gastric antrum starting 3-5 cm proximal to the pylorus front section to the fiber by fiber to the muscular pyloric, then closing the inlet tunnel by hemostatic clips.
An evaluation of symptoms by the Gastroparesis Cardinal Symptom Index (ISCC) of the quality of life of the patient Assessment of upper gastrointestinal disorders-Quality Of Life (PAGI-QoL), SF-36 and gastrointestinal Quality of Life Index (GIQLI ) and gastric emptying by a scintigraphic gastric emptying will be carried out at 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patient with refractory gastroparesis to drug treatment (post-diabetic, post-Sjogren, postsurgical or idiopathic)
- •Signed Consent
- •Affiliate or beneficiary of a French social security scheme
排除标准
- •Contraindications to gastroesophageal gastroduodenal endoscopy,
- •Early Unable to follow protocol,
- •Contraindications to general anesthesia,
- •Can not Stop anticoagulants for the gesture,
- •Can not stop antiplatelet agents for the gesture,
- •Pregnant or lactating women,
- •Gastric resection surgery History of pyloric
- •Patients under guardianship, curatorship or safeguard justice,
- •Disorders of hemostasis against-indicating the endoscopic procedure.
结局指标
主要结局
Number of technical success for endoscopic pylorotomy on the total number of gestures.
时间窗: 3 months
Technical feasibility will be the feasibility of endoscopic pylorotomy gesture by the technique of the tunnel.
次要结局
- Incidence of adverse events of pylorotomy(3 months)
- Assessment of gastroparesis severity symptom using the Gastroparesis Cardinal Symptom Index (GCSI)(Baseline, 1 month and 3 month)
- Assessment of functional health and well-being from the patient's point of view (SF-36)(Baseline, 1 month and 3 month)
- Assessment of Quality of Life in Upper Gastrointestinal Disorders (PAGI-QOL)(Baseline, 1 month and 3 month)
- Ratio between the diameter of the pyloric canal and the pyloric pressure(Baseline and 3 months)
- Assessment of gastric emptying scintigraphy(baseline and 3 months)
- Assessment of Quality of Life in Gastrointestinal disease (GIQLI)(Baseline, 1 month and 3 month)
- Consumption of gastric prokinetic drugs(3 months)