Tissue Markers Predictive of Early Stenosis in the Arterovenous Fistula for Hemodialysis
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
- Identify any predictive or favoring tissue markers of early stenosis in AVF for hemodialysis.
研究概览
简要总结
The study involves the recruitment of two populations. POPULATION 1 (surgical sample of excess venous segment): at least 75 consecutive patients, enrolled according to the inclusion criteria and subjected to first AVF surgery as part of the normal care pathway, at the Metropolitan Vascular Surgery Unit, Dir. Prof. Mauro Gargiulo of the S.Orsola-Malpighi University Hospital.
POPULATION 2 (surgical sample of arterialized venous segment from removal of previous AVF): at least 75 consecutive patients, enrolled according to the inclusion criteria and subjected to reoperation for correction of complication and/or new AVF by proximalization, as part of the normal care pathway, at the Metropolitan Vascular Surgery Unit, Dir. Prof. Mauro Gargiulo of the S.Orsola-Malpighi University Hospital.
详细描述
The following study will enroll two cohorts of patients: 75 patients from Population 1 and 75 patients from Population 2, according to the inclusion criteria. Since this is an exploratory study, this number is considered sufficient to observe and compare tissue markers associated with early AVF stenosis.
Patients will be treated according to clinical practice in accordance with the physician's judgment.
The study includes: the recruitment of patients from the two study populations, the obtaining of the surgical specimen from both populations and its sending to the Pathology Department, as part of the normal care pathway, the execution of three tissue samples at the Pathology Department: (i) a sample frozen in liquid nitrogen and stored in an ultrafreezer at -80°C for RT-PCR analysis; (ii) a sample placed in PBS for cell culture; (iii) the remainder of the sample fixed in formalin, embedded in paraffin and processed according to the normal care pathway and histological diagnosis. 2 µm slices will be cut from the paraffin block for histological staining and histochemical and IIC investigations; execution of cell culture investigations and execution of RT-PCR investigations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
入选标准
- •Age greater than or equal to 18 years;
- •Patients candidates for first AVF for hemodialysis or correction of AVF complication, as part of the normal care pathway;
- •Obtaining informed consent signed by the patient
排除标准
- 未提供
研究组 & 干预措施
First FAV
Group of patient with first FAV
干预措施: Identification any tissue markers predictive or favoring early stenosis in AVF for haemodialysis. (Biological)
Secondary FAV
Group of patients with reintervention of FAV
干预措施: Identification any tissue markers predictive or favoring early stenosis in AVF for haemodialysis. (Biological)
结局指标
主要结局
Identify any predictive or favoring tissue markers of early stenosis in AVF for hemodialysis.
时间窗: From the first patient entrolled, up to the 150th patient, an average of 6 years
Biomarkers of the treated fistula are histologically examined
次要结局
- Different expression of tissue markers before and during dialysis.(From the first patient enrolled to the 150th patient, an average of 6 years)
- Markers differences between Basilic and cephalic vein(From the first patient enrolled, up to the 150th patient, up to 6 years)