Assessment of Pancreatic Fibrosis as a Prognostic Factor of Its Course
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- correlation between non-invasive and invasive markers of pancreatic fibrosis
研究概览
简要总结
In chronic pancreatitis, pancreatic fibrosis impairs the ducts patency and secretion and contributes to chronic pain. Another complication of long CP presence is pancreatic exocrine insufficiency (PEI) that is present in 30-90% of patients with CP. Currently, there are no reliable techniques for non-invasive assessment of the pancreatic fibrosis degree. The only accurate method for determining the severity of fibrotic changes in the pancreas is histological examination. Despite the high informativeness of this method, its use is limited by the necessity to obtain biopsy specimens of sufficient diagnostic volume or surgical material, which is associated with the complications risk of an invasive procedure. This makes it impossible to assess the degree of fibrosis in all the patients with pancreatic diseases.
It is possible to overcome the limitations by applying non-invasive diagnostic techniques, the development and grounding of which is planned within the framework of the Project.
详细描述
Hypothesis The degree of fibrotic changes according to the histological examination can be comparable to the degree of fibrosis of the pancreas identified by non-invasive radiology and laboratory diagnostic methods.
Aim To identify the relationship between the degree of fibrosis in the pancreas assessed by the histological examination and a complex of non-invasive radiology and laboratory diagnostic procedures.
Materials and methods Study design Prospective single-center observational study Inclusion Criteria
- age 18-99 years
- pre-planned pancreatic resection
- consent of the patient to participate in the study Exclusion Criteria
- inability to sign informed voluntary consent at the time of an inclusion to the study
- the impossibility of obtaining clinical data, data of instrumental, laboratory studies, and histological examination of the material obtained during surgical treatment.
Variables
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-99 years
- •pre-planned pancreatic resection
- •consent of the patient to participate in the study
排除标准
- •inability to sign informed voluntary consent at the time of an inclusion to the study
- •the impossibility of obtaining clinical data, data of instrumental, laboratory studies, and histological examination of the material obtained during surgical treatment.
结局指标
主要结局
correlation between non-invasive and invasive markers of pancreatic fibrosis
时间窗: 3 years
fibrotic changes according to the histological examination can be comparable to the degree of fibrosis of the pancreas identified by non-invasive radiology and laboratory diagnostic methods
次要结局
未报告次要终点