Surgical Versus Percutaneous Drainage in the Management of High Grade Pancreatic Trauma: A Prospective Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 28-day mortality
研究概览
简要总结
High-grade pancreatic injury is rare, and the reported complication and mortality are high.
The optimal management strategy according to high-grade injuries remains controversial.
The present study compares surgical drainage with percutaneous drainage in the management of High-grade pancreatic trauma.
详细描述
High-grade pancreatic trauma (HGPT), while uncommon, presents challenging diagnostic and therapeutic dilemmas to trauma surgeons. Multiple management strategies to HGPT have been reported, which was associated with a high level of morbidity and mortality rate. Besides, few prospective studies have investigated the optimal management strategy of patients with HGPT.
We aimed to compare surgical drainage with percutaneous drainage in the management of HGPT. 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 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 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 a usual practice, post-operative treatment will be prescribed at the investigator's discretion, with the help of an acre-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, treatment history, post-operative treatment if prescribed, treatment history between surgery and image logical diagnosis are recorded. Clinical data are also collected 12months after discharge during a scheduled visit organized as usual practice, for long-term study.
Several studies will be performed along with the cohort setting-up:
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 high-grade pancreatic trauma by surgery
- •Patient diagnosed with high-grade pancreatic trauma by computed tomography
- •Patient diagnosed with high-grade pancreatic trauma by Endoscopic retrograde cholangiopancreatography (ERCP)
- •Patient diagnosed with high-grade pancreatic trauma by Magnetic resonance cholangiopancreatography (MRCP)
排除标准
- •The patient underwent chemotherapies or radiotherapy
- •Immune system disease
- •Low-grade pancreatic trauma
- •Accompanied by severe trauma to other organs
- •End-stage chronic organ failure
- •With multiple severe injuries
- •Died within 24 h of admission
- •Younger than 18 years
结局指标
主要结局
28-day mortality
时间窗: 28 days
All cause mortality within 28 days
次要结局
- Days to regular diet(Through study completion, an average of 6 months)
- Postoperative 28-day adverse effects(28 days)
- Hospital length of stay(Through study completion, an average of 6 months)
- Pancreatic associated complications(Through study completion, an average of 1 year)
- Days on total parenteral nutrition(Through study completion, an average of 6 months])
- Time to enteral nutrition(Through study completion, an average of 6 months)
- Non-pancreatic associated complications(Through study completion, an average of 1 year)
- Systematic complication(28 days)
- Intensive Care Unit length of stay(Through study completion, an average of 6 months)
- Organ failure(28 days)
- Days to clear liquids(Through study completion, an average of 6 months)
研究者
Gao Tao
Dr
Nanjing PLA General Hospital