Pancreatic Injury and Corresponding Management Outcome (PICO): Prospective Multicenter Cohort Study From the Tertiary Referral or University-affiliated Hospitals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 30-day mortality
研究概览
简要总结
Pancreatic injury is a relatively rare and result in significant morbidity and mortality.
Estimates for the incidence of pancreatic injury range from 0.2-12% of abdominal traumas. Many factors, such as patient stability, the acuity of concomitant life-threatening injuries, and the need for damage control procedures must therefore be balanced when considering the proper approach to pancreatic injury management.
However, few prospective studies have investigated the perioperative management of patients with pancreatic trauma.
详细描述
Pancreatic trauma, while uncommon, presents challenging diagnostic and therapeutic dilemmas to trauma surgeons. Indeed, injuries to the pancreas have been associated with reported morbidity rates approaching 45%.
The disease 's characterization at a specific therapeutic level will allow for a better management of patients treated. To do so, the strategy is to integrate precise prospective clinical records extensive clinical treatment data in a large cohort of patients.
All the clinical departments, participating in the study, include patients, with a tight collaboration between Trauma, Intensive Care and Surgery departments. Demographics and clinical parameters are collected in a database.
Once after the diagnosis is confirmed, the inclusion of patients is performed, before a scheduled hospital management, and after eligibility criteria checking, and consent form signature. During clinical management, several samples are collected: blood samples and surgical specimens. As usual practice, post-operative treatment will be prescribed at investigator's discretion, with help of a pre-established algorithm. Several samples are also collected during this exam (blood and biological tissue sample).
At the same time as these managements, clinical data regarding medical history, pre-hospital treatment history, surgical history, treatments history, post-operative treatment if prescribed, treatments history between surgery and imageological diagnosis are recorded. Clinical data are also collected 12 months after discharge during a scheduled visit organized as usual practice, for long-term study.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with pancreatic trauma by surgery
- •computed tomography
- •Endoscopic retrograde cholangiopancreatography (ERCP)
- •Magnetic resonance cholangiopancreatography (MRCP)
排除标准
- •The patient underwent chemotherapies or radiotherapy
- •immune system disease
- •end-stage chronic organ failure
- •moribund cases with multiple severe injuries
- •died within 24 h of admission
- •younger than 18 years
结局指标
主要结局
30-day mortality
时间窗: 30 days
All cause mortality within 30 days
次要结局
- Days to regular diet(Through study completion, an average of 6 months)
- Operational intervention(30 days)
- Postoperative 30-day adverse effects(30 day)
- Systematic complication(30 days)
- Non-pancreatic associated complications(Through study completion, an average of 1 year)
- pancreatic associated complications(Through study completion, an average of 1 year)
- Organ failure(30 days)
- Time to enteral nutrition(Through study completion, an average of 6 months)
- Days on total parenteral nutrition(Through study completion, an average of 6 months)
- Days to clear liquids(Through study completion, an average of 6 months)
- Hospital length of stay(Through study completion, an average of 6 months)
- Intensive Care Unit length of stay(Through study completion, an average of 6 months)
研究者
Gao Tao
Clinical Professor
Nanjing PLA General Hospital