A Multimodal Approach to Diagnose Patients With Chronic Pancreatitis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Peak enzyme Concentration IE
研究概览
简要总结
To develop a new standardized multimodal diagnostic approach to CP considering:
WP 1: Fat in faeces and functional testing; the combination of tests has to be easy to practice, should take as little time as possible and discomfort for the patient has to be minimized WP 2: Advanced ultrasonography and imaging modalities. The focus is on validating standard parenchymal, contrast enhanced and functional ultrasound compared to a modern imaging standard. (CT, EUS, MRI)
To evaluate the reliability and feasibility of these novel methods in healthy volunteers; AND
To compare findings in known severe CP patients and different stages of pancreatic insufficiency in patients with CP.
详细描述
WP 1: Exocrine function testing
Aims:
Evaluating an endoscopic short test in patients with suspected pancreatic disease. Main focus on Chronic pancreatitis. (Collaborations to other patient groups in other protocols and to a group of healthy controls. )
Methods:
Secretintsimulated Endoscopic short test With duodenal sampling 30-45 minutes after secretin stimulation. Measurement of duodenal enzymes and duodenal bicarbonate concentration.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patients will be included from the Department of Medicine at Haukeland University Hospital in Norway. The Marseille-Rome diagnostic criteria will be used. Patients will be scored according to the Layer score. The symptoms should be unrelated to other systemic diseases.
排除标准
- •Personality disturbances and alcohol consumption 24 hours prior to the study. Any other diseases and drugs associated with malabsorption; pregnancy or lactating women; heart disease or allergy against MR or ultrasound contrast agents.
结局指标
主要结局
Peak enzyme Concentration IE
时间窗: 5 Years
Development of pancreatic insufficiency
时间窗: 5 years
次要结局
- peak amylase(5 Years)
- Development of pain(5 years)
- development of diabetes(5 years)
- weight loss(5 years)
研究者
Georg Gjorgji Dimcevski
MD
Haukeland University Hospital