Metal Clip and Endoloop Mediated Endoscopic Cardioplication (ECLC) for the Treatment of Gastroesophageal Reflux Disease (GERD):a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 35
- 主要终点
- The total score of the GERD-HRQL questionnaire
研究概览
简要总结
Endoscopic full-thickness plication (EFTP) of cardia/fundus has been shown effective in treating GERD patients. However, EFTP requires proprietary equipment that are not available in many countries. Here, we designed a metal clip and endoloop mediated cardioplication (ECLC) procedure to achieve EFTP.
详细描述
Endoscopic full thickness pancreatography (EFTP) is a minimally invasive surgical method that has emerged in recent years for the treatment of severe gastroesophageal reflux disease. This surgery requires the use of disposable patented instruments, which is expensive and has not entered the domestic market. To this end, we have innovatively developed an endoloop mediated cardioplication (ECLC) that only requires metal clips and nylon ropes. The most common and inexpensive endoscopic consumables can achieve the effect of tightening the lower esophageal sphincter, which is expected to be used for the treatment of gastroesophageal reflux disease. The ECLC surgery first incises the mucosa and submucosa on the small curvature side and posterior side (approximately 3/4 of the total circumference) of the diaphragm level cardia until smooth muscle fibers are exposed; Fix the metal clip covered with nylon rope on the exposed smooth muscle layer, and finally tighten the nylon rope to achieve full folding of the cardia. After the surgery, the patient fasted overnight and received intravenous PPI treatment. On the second day after surgery, a fluid diet was restored and discharge was possible. ECLC is simple, easy to operate, relatively inexpensive, and minimally invasive, and is expected to become a new method for treating severe gastroesophageal reflux disease.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years old
- •hiatal hernia ≤ 3cm
- •Sliding hernia ≤ 3cm
- •Classic reflux symptoms (heartburn, reflux) lasting for more than 6 months
- •Daily PPIs ≥ 6 months
- •Esophagitis (Los Angeles grade) Grade A, B, and C
- •Gastroesophageal valve I-III grade (Hill grade)
- •Pathological esophageal acid exposure (percentage of time with 24-hour esophageal PH<4 <4.2%)
- •Normal or near normal esophageal movement (through manometry or impedance)
- •The lower esophageal sphincter pressure (LESP) is between 5-15mmHg
- •DeMeester score ≥ 14.7 or total reflux episodes>73
- •Patients who sign an informed consent form and voluntarily accept surgical expenses.
排除标准
- •BMI>35kg/m2
- •Barrett's esophagus
- •Hill IV level
- •Large esophageal hiatal hernia>3cm
- •Esophagitis (Los Angeles grade) Grade D
- •Peptic ulcer
- •Primary esophageal motility disorders such as achalasia
- •Previous esophageal or gastric surgery
- •Uncontrolled systemic diseases
- •Pregnancy or planned pregnancy within 1 year
- •Have a history of cervical fusion surgery, esophageal diverticulum, scleroderma or dermatomyositis, eosinophilic esophagitis, liver cirrhosis or coagulation dysfunction, immune system diseases
- •Patients deemed unsuitable for inclusion by researchers.
结局指标
主要结局
The total score of the GERD-HRQL questionnaire
时间窗: at 3 month follow- up
Questionnaire (GERD-HRQL) : Total Score: Calculated by summing the individual scores toquestions 1-15 Greatest possible score ( worst symptoms)= 75 Lowest possible score ( no symptoms)= 0 Heartburn Score: Calculated by summing the individual scores to questions 1-6 . Worst heartburn symptoms = 30 No heartburn symptoms= 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate heartburn elimination. Regurgitation Score: Calculated by summing the individual scores to questions10-15. Worst regurgitation symptoms = 30 No regurgitation symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate regurgitation elimination.
次要结局
- Total score of GERD GerdQ and GERD HRQL questionnaires(at 6 and 12 month follow- up)
- Healing status of reflux esophagitis and damaged mucosa(at 3, 6, and 12 months)
- PPI usage(at 3, 6 and 12 month follow- up)
- Esophageal acid reflux and DeMeester score(at 3, 6, and 12 months follow- up)
- Total score of GERD GerdQ questionnaire(at 3 month follow- up)
- Safety evaluation indicators(at 0, 3, 6, and 12 months)
研究者
Lu Jiaoyang
professor
Qilu Hospital of Shandong University