Prevention of Progression of Duodenal Adenomas to Cancer in Patients With Familial Adenomatous Polyposis (FAP)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 5
- 主要终点
- Change in number and size of duodenal adenomas (assessed directly and by evaluation of video and photographic material from endoscopic procedures)
研究概览
简要总结
Duodenal carcinomas are the leading cause of mortality in patients with Familial Adenomatous Polyposis (FAP) who underwent prophylactic colorectal surgery. The purpose of this study is to determine wether celecoxib combined with ursodeoxycholic acid is an effective chemoprevention strategy to influence the progression of duodenal adenomas to carcinomas in patients with FAP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •Patients with Familial adenomatous Polyposis: APC-mutation identified or more than 100 colorectal polyps on diagnosis
- •Spigelman score of duodenal adenoma equal to II or III
排除标准
- •Incapability of signing informed consent
- •Active gastric or duodenal ulcer, gastrointestinal bleeding
- •Cardiovascular disease or risk:
- •Congestive cardiac failure: NYHA class II to IV
- •Proven ischemic heart disease and/or cerebrovascular disease
- •Risk factors: hypertension, hyperlipidaemia, diabetes mellitus, family history of cardiovascular events (≥2 first degree family members <55 years)
- •Renal dysfunction: creatinine clearance below 50mL/min
- •Liver dysfunction: albumin below 25 g/L or Child-Pugh-score equal to or below 10
- •Known allergic reaction to sulfonamides, NSAIDs or ursodeoxycholic acid
- •Use of NSAIDs or ursodeoxycholic acid for more than 1 week during the 6 months prior to the start of the study
- •Use of lithium
- •Symptomatic gallstones
- •Inflammatory bowel disease
- •(Possible) pregnancy or breast feeding
研究组 & 干预措施
Group 1
Patients receive oral celecoxib twice daily and oral placebo twice daily
干预措施: Celecoxib (Drug)
Group 1
Patients receive oral celecoxib twice daily and oral placebo twice daily
干预措施: Placebo (Drug)
Group 2
Patients receive oral celecoxib twice daily and oral ursodeoxycholic acid twice daily
干预措施: Celecoxib (Drug)
Group 2
Patients receive oral celecoxib twice daily and oral ursodeoxycholic acid twice daily
干预措施: Ursodeoxycholic acid (Drug)
结局指标
主要结局
Change in number and size of duodenal adenomas (assessed directly and by evaluation of video and photographic material from endoscopic procedures)
时间窗: Baseline, 6 months
次要结局
- Cell proliferation, in normal mucosa and adenomas (if present)(Baseline, 6 months)
- Biliary acid profile (if present)(Baseline, 6 months)