Tracking the ENcapsulation of Pancreatic Collections in Acute Necrotizing Pancreatitis. A Serial MRI Based Prospective Study (MRI-ENCAP Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Timing of Encapsulation
研究概览
简要总结
The goal of this study is to investigate the encapsulation of fluid collections in patients with ANP using serial MRI.
The main questions it aims to answer are:
- Evaluating the timing of encapsulation of necrotic fluid collection using serial non-enhanced MRI.
- Identifying the factors that affect the timing of encapsulation of necrotic fluid collections Participants will undergo serial MRI scans (all with the same protocol) performed starting at day 15. Subsequent scans will be performed at 5 days interval till the clinically significant encapsulation (for all the collections in an individual patient) is seen or patients are excluded from the protocol due to intervention.
详细描述
Consecutive patients with ANP presenting to the hospital within 2 weeks from the pain onset will be recruited. They will undergo serial non-contrast MRI starting at day 15 and every 5 days thereafter, till complete encapsulation of PFC. Ultrasound evaluation of the collection will be performed on the day of MRI by a radiologist not involved in evaluation of MRI. The site and volume of collection as well as thickness and completeness of the capsule and solid content within the collection will be recorded independently by two radiologists. The timing of clinically significant (>50% of PFC show capsule) and complete encapsulation will be recorded. The proportion of collections encapsulating in each week after 2nd week of illness will be recorded. The association between timing of encapsulation and clinical/biochemical parameters will be assessed. The correlation between the degree of encapsulation and percentage of solid components will also be documented. Multivariate analysis will be performed to identify factors associated with timing of encapsulation.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute necrotizing pancreatitis
- •Presentation to hospital within 2 weeks of pain onset
- •Willing to give informed consent
排除标准
- •Contraindications to non- enhanced MRI (Claustrophobia, cardiac pacemaker, cochlear implant).
- •Acute on chronic pancreatitis
- •Mechanical ventilation, ionotropic support (precluding safe environment in MRI).
- •Drainage or aspiration of a collection prior to recruitment
结局指标
主要结局
Timing of Encapsulation
时间窗: 1-2 months after initial MRI
MRI scans will be performed
次要结局
未报告次要终点
研究者
Pankaj Gupta
Associate Professor
Post Graduate Institute of Medical Education and Research, Chandigarh