Resolving Bile Reflux by Lanreotide in Patients With Roux-en-Y Gastrojejunostomy
试验速览
- 阶段
- 2 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Los Angeles criteria for reflux esophagitis
研究概览
简要总结
Somatostatine induces a dose-dependent reduction of postprandial plasma cholecystokinin (CCK) secretion with a concomitant inhibition of postprandial gallbladder contraction, abolishing almost completely bile salts output from the gallbladder. Somatostatine is also known to decrease acid production with significant increase of intragastric pH. In this way, somatostatine could influence acid as well as non-acid reflux by decreasing gallbladder emptying and decreasing acid secretion.
Purpose of the study is to evaluate the efficacy of lanreotide autogel 120 mg on symptoms and endoscopic lesions in patients with an endoscopic gastrointestinal reflux esophagitis that cannot be controlled with classic therapy.
详细描述
Patients presenting with persistent esophagitis on endoscopy while on proton pump inhibitors (PPI) treatment will receive a maximal therapy consisting of 2 x 40 mg of PPI before the meals (morning and evening) and a H2 blocker before bedtime (standard practice). They will be reevaluated endoscopically and clinically 2 months later (standard practice). If reflux persists, objectivized by impedancemetry (standard practice), they will be asked to participate in this study.
Lanreotide autogel 120 mg deep subcutaneously every 4 weeks will be added to the treatment. A total of 3 injections per patient have been foreseen in this proof of concept study.
Patients will be reevaluated clinically after 2, 4 and 8 weeks. At the end of the study a new upper gastrointestinal endoscopy and impedancemetry will be performed.
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
- 是
入选标准
- •Persistent endoscopic reflux in spite of maximal medical therapy with PPI 2 x 40 mg (before breakfast and dinner) and 300 mg of H2 blocker ranitidine (at bedtime).
- •The Los Angeles classification (LA) will be used to evaluate endoscopic reflux. Any distal esophageal ulcer with negative biopsy is also diagnostic for reflux.
- •Persistent reflux is defined as:
- •No reflux complaints but continuing endoscopic lesions and positive impedancemetry.
- •Reflux complaints with continuing endoscopic lesions and positive impedancemetry.
- •Reflux complaints without endoscopic lesions but positive impedancemetry.
排除标准
- •Pregnancy or inadequate anticonception, breast feeding.
- •Negative impedancemetry.
- •Diabetes.
- •Placement of a gastric ring for weight loss.
研究组 & 干预措施
Lanreotide
Lanreotide autogel 120mg injection every 4 weeks (every patient will receive 3 injections)
干预措施: Lanreotide (Drug)
结局指标
主要结局
Los Angeles criteria for reflux esophagitis
时间窗: 4 weeks after the last injection with lanreotide
Endoscopy at the start of the study will be compared with endoscopy at the end of the study.
次要结局
未报告次要终点
研究者
Kim Moubax
Dr. Kim Moubax, gastro-enterology
Universitair Ziekenhuis Brussel