Hyaluronic Acid as a Novel Therapeutic Approach for Patients With GERD: a Single-center Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Assessment of esophageal transit and gastric emptying
研究概览
简要总结
Gastroesophageal reflux disease (GERD) remains one of the most common pathologies seen among gastroenterologists, surgeons, and primary care physicians. The high prevalence of this condition lead to further investigations in its prevention, diagnosis, and management. For the treatment of this chronic condition, improvement in quality of life and long-term durability should be considered.
Nowadays, proton pump inhibitors (PPIs) are considered the mainstay in the treatment of the patients with GERD; however, due to the increasing concern related to its safety in its long-term use and the over prescription of these drugs, new surgical and endoscopic interventions have emerged.
A local treatment based on injections of hyaluronic acid, a natural nonimmunogenic mucosal defense, in the lower esophageal mucosa is a tentative treatment option for these patients. Based on this, the investigators pursue to assess the effects of hyaluronic acid in gastroesophageal reflux control.
详细描述
GERD is one of the most common digestive pathologies, with a prevalence between 20% and 40% of adults. For the treatment of the disease, proton pump inhibitors (PPIs) have undoubtedly shown effective results; however, in around 30% of patients the complete resolution of symptoms fails.
For the latter, new therapeutic options should be considered. As a modern well-tolerated approach, and for local treatment, hyaluronic acid (HA) appeared to be an option for symptoms relief. HA is a glycosaminoglycan that acts as a natural defense for esophageal mucosa, able to organize the reticular structure as a filter to prevent the diffusion of high molecular substances. In addition, one of its remarkable features is the induction and control of epithelial cells turnover improving the re-epithelization process and the ulcer healing. In addition, hyaluronic acid compounds have shown no migration from the injection site in up to a three-year period.
Based on the above, the investigators aim to assess the effectiveness of hyaluronic acid in gastroesophageal reflux control, to considered it as an alternative effective treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults >18 years old
- •Patients with diagnosis of GERD (distal esophageal acid exposure time > 6% on 24hour ambulatory pH-impedance monitoring)
- •Patients with abnormal distal esophageal acid exposure time (4%-6%) on 24-hour ambulatory pH-impedance monitoring
- •Patients who authorized for endoscopic approach.
排除标准
- •Pregnancy
- •Any clinical condition which makes endoscopy inviable.
- •Patients with severe anatomic conditions such as esophageal strictures, Barret´s esophagus, hiatal hernias.
- •Previous esophageal surgery.
- •Patients with a history of upper gastrointestinal neoplasia.
- •Inability to provide informed consent
结局指标
主要结局
Assessment of esophageal transit and gastric emptying
时间窗: Up to 1 month
The assessment of gastrointestinal transit through barium x-ray (upper gastrointestinal series) to identify any post-procedural functional motility changes. The patients will be assessed one month after the procedure.
Change in health-related quality of life
时间窗: up to 6 months
Effect in the Gastroesophageal Reflux Disease Health-related quality of life through the Northwestern Esophageal Quality of Life (NEQOL) scale. NEQOL, a 14-item, single scale measure of Health-related quality of life (HRQOL), allows for rapid assessment in a clinical setting. The patients will be assessed at the beginning, and six months after the procedure.
Acid exposure to the distal esophagus after intervention
时间窗: Up to 6 months
The response to the therapy will be determined by the acid exposure to the distal esophagus, measured through pH monitoring and evaluated by 24-h acid exposure time (AET). AET is defined as the total time for which the pH in the distal esophagus is below 4 divided by the total duration of Multichannel Intraluminal Impedance (MII)-pH monitoring. It is expressed in percentages. AET of more than 4% is considered an abnormal distal esophageal acid exposure. The patients will be assessed at the beginning, one and six months after the procedure.
次要结局
- Safety of HA injections in GERD(Up to 6 months)
- Evaluation of lower esophageal sphincter (LES) distensibility and pressure by EndoFLIP(Up to 1 month)
研究者
Carlos Robles-Medranda
Head of the Endoscopy Division
Instituto Ecuatoriano de Enfermedades Digestivas