Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in Patients With Familial Adenomatous Polyposis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- polyp size
研究概览
简要总结
The objective of this study is to investigate the feasibility for the treatment of precancerous peri-ampullary FAP polyps in the duodenum using low-thermal argonplasma.
详细描述
Familial adenomatous polyposis (FAP) is an autosomal dominantly inherited disorder, which results from a germ line mutation in the APC (adenomatous polyposis coli) gene. FAP is characterized by the formation of very high number of colorectal adenomatous polyps which could cause the development of colorectal cancer in the 5th decade of life. After colon surgery patients are still at risk of developing upper GI cancer e.g. in the duodenum. Because of the continuing risk for the development of duodenal cancer, regular endoscopic surveillance is recommended for these patients.
In this study a new APC modality (Precise mode E1) applied for the remission of FAP polyps during routine endoscopic surveillance is suggested. Argonplasma coagulation (APC) is widely used for the ablation and coagulation of superficial lesions in the GI tract. The application of high thermal tissue destroying APC in the duodenum is challenging due to the anatomy of the duodenal wall which is thin and therefore susceptible to thermal damage.
The application of low-thermal argonplasma in the GI tract could be just as useful as it was suggested for the treatment of neoplastic tissue in gynecology. Low-thermal APC using Erbe Standard 3.2 mm FiAPC probe and Precise mode was successfully applied for the remission of cervical intraepithelial neoplasia. The formation of reactive oxygen and nitric oxide species has been discussed as trigger for the effect on neoplasia tissue of low-thermal argonplasma.
Regarding current knowledge this is the first application of this APC modality in the GI tract.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed FAP disease
- •duodenal polyposis with recommendation of a follow-up EGD in 12 months corresponding to stage III (7-8 points) according to Spigelman
- •presence of duodenal polyps < 10 mm
- •written Informed Consent
排除标准
- •presence of lesions that are suspicious of the presence of high-grade dysplasia or carcinoma
- •pregnancy or breastfeeding
- •severe general illnesses (permanent ASA (American Society of Anesthesiologists) III and IV) who do not prognostically benefit from follow-up, life expectancy < 1 year
- •severe coagulopathy
- •any visible state of duodenal surface that makes APC treatment impossible, e.g. inflammation, stricture, stenosis or scarring changes/scar areas
结局指标
主要结局
polyp size
时间窗: 12 months
Significant reduction in the size of duodenal polyps at the next follow-up appointment
polyp number
时间窗: 12 months
Significant reduction in the number of duodenal polyps at the next follow-up appointment
次要结局
- success rate(12 months)
- balloon dilatations(12 months)
- need for surgical intervention(24 hours)
- acute dysphagia(24 hours)
- nausea(4 days)
- signs of bleeding(4 days)
- fever(4 days)
- dysphagia(12 months)
- acute haematemesis(24 hours)
- acute severe hemoglobin drop(24 hours)
- blood transfusion(24 hours)
- acute abdominal pain(24 hours)
- acute rise of temperature(24 hours)
- EGD (esophago-gastro-duodenoscopy) time(during EGD; up to 45 minutes)
- therapy time(up to 30 minutes)
- abdominal pain(12 months)
- acute hemoglobin drop(24 hours)
- endoscopic hemostasis(24 hours)
- treatment of perforation(24 hours)
- postprandial pain(12 months)
- feeling of fullness(4 days)
- emesis(12 months)
- need for physician help(4 days)
研究者
Prof. Dr. Thomas Rösch
Prof. Dr. Thomas Roesch Medical Director, Interdisciplinary Endoscopy Department and Clinic University Hospital Hamburg-Eppendorf
Universitätsklinikum Hamburg-Eppendorf