Observational Study in Chyle Leak After Pancreatic Operation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Chylous fistula
研究概览
简要总结
With the development of pancreatic surgery, the surgeon has put more emphasis on chylous fistula as the postoperative complications in recent years. The diagnostic criteria and treatment methods about chylous leakage have been developed and improved in clinical practice. However, there remains controversy about the high risk factors and efficient control measures during the perioperative period.
详细描述
Chylous fistula is one of the common complications after pancreatic operation, whose incidence is about 10%. The delayed diagnosis or wrong treatment in the perioperative period may lead to refractory chylous ascites, water-electrolyte imbalance, malnutrition, immune dysfunction, secondary infection and other complications. In the past, chylous fistula, as the postoperative complication, is common in abdominal aortic surgery, gynecological malignancies accompanied with posterior peritoneum lymphadenectomy and spinal surgery, etc. But chylous fistula after pancreatic operation did not attract enough attention. The comparative study or case analysis is lacked in relevant reports and there is no consensus on diagnostic criteria. In addition, once it occurs after pancreatic operation, the rehabilitation of patients will be affected, increasing the burden of hospitalization and even endangering the lives of patients due to the lack of diagnosis and treatment experience of specialists. The International Study Group of Pancreatic Surgery (ISGPS) proposed relevant definitions under the background of no unified diagnostic criteria of chylous fistula after pancreatic operation. But this definition still has some shortcomings; for example, it lacks the value of clinical guidance and research implementation. Moreover, how to take targeted preventive measures, choose the optimal treatment method and avoid complications, and whether there is a superior treatment method need to be further considered and investigated. Therefore, we performed this study, so as to better improve the relevant definition and provide guidance for the diagnosis and treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a diagnosis of CL after pancreatic operation
- •Aged 18 or older
- •Of either sex
排除标准
- •No specific exclusion criteria will be applied to a participant as long as the participant is eligible for the trial
结局指标
主要结局
Chylous fistula
时间窗: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
The determine of chylous fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria.
次要结局
- Extubation time(From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days)
- Hospital stays(From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days)
- Number of hospitalizations(From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days)
- Mortality(From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days)