Per Oral Endoscopic Myotomy (POEM) for Esophagogastric Junction Outflow Obstruction (EGOO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in dysphagia severity
研究概览
简要总结
This research is being done to study an endoscopic procedure called "POEM" as a less invasive alternative to surgery in people with esophagogastric junction outlet obstruction (EGOO).
详细描述
Patients with EGOO have difficulty swallowing and/or chest pain. Previously we were not able to distinguish this disease from achalasia. Achalasia is a disease which is characterized by a progressive difficulty with swallowing. It is caused by failure of relaxation of the lower esophageal sphincter (sphincter between esophagus and stomach) along with an essentially aperistaltic esophageal body.
However, EGOO patients have abnormal lower esophageal sphincter relaxation with some preserved peristaltic activity. Because they have some peristalsis, these patients are not diagnosed with achalasia.
Currently, a new diagnostic method, known as high-resolution manometry (HRM), can identify EGOO patients. EGOO patients usually do not respond well to medical treatment and surgery is required in most cases to reduce the pressure of lower esophageal sphincter muscles. This procedure is called "Heller myotomy".
Recently, a new endoscopic method for reducing lower esophageal sphincter pressure has been developed. This method, per-oral endoscopic myotomy (POEM) is now being performed clinically throughout the world, including Johns Hopkins Hospital. The technique utilizes a flexible endoscope to tunnel beneath the esophageal surface layer and cutting muscle fibers of the lower esophagus and upper stomach. POEM is an alternative to invasive surgery with fewer complications. POEM is performed safely at Johns Hopkins Hospital for achalasia patients. Outcomes of POEM have been excellent with greater than 90% positively responding to endoscopic myotomy. Patients with EGOO are being diagnosed more often due to increased use of HRM. They respond poorly to endoscopic therapies but well to surgical myotomy. POEM is the endoscopic equivalent to surgical intervention and represents a less invasive approach to treating these patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive adult patients (18-70 years of age) with symptomatic dysphagia (dysphagia score ≥2) EGOO that is diagnosed by high resolution manometry.
- •Ability to give informed consent.
排除标准
- •Unable to give informed consent
- •Pregnant or breastfeeding women (all female patients if child-bearing age will undergo urine pregnancy testing prior to endoscopy)
- •Acute gastrointestinal bleeding
- •Coagulopathy defined by prothrombin time < 50% of control; partial thromboplastin time (PTT) > 50 sec, or international normalized ratio (INR) > 1.5), on chronic anticoagulation, or platelet count <75,000
- •Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy
- •Prior esophageal or gastric surgeries
- •Cirrhosis with portal hypertension, varices, and/or ascites
- •Active Esophagitis
- •Hiatal hernia larger than 2cm
- •Barrett's esophagus
- •Eosinophilic esophagitis
- •Esophageal stricture
- •Esophageal malignancy
- •Large esophageal diverticulum
- •Mechanical obstruction to esophageal outflow or infiltrative esophageal or gastric disorders.
- •Prior esophageal Botox injection
结局指标
主要结局
Change in dysphagia severity
时间窗: 2 and 6 months
Dysphagia will be measured by Dysphagia score and Eckhardt score at 2 and 6 months after the procedure (The Eckhardt score takes into consideration symptoms of dysphagia, chest pain, regurgitation and chest pain)
次要结局
- Length of hospital stay(2 years)
- Procedural times(2 years)
- Complication rate(2 years)
- Post procedural Gastroesophageal reflux disease (GERD)(2 months)
- Resolution in Esophago-gastric junction (EGJ) outflow obstruction by HRM performed 2 months after the procedure(2 months)
- Time to resume normal diet(2 years)
- Change in participants' quality of life(2 and 6 months)