Clinically Relevant Postoperative Pancreatic Fistula After Pancreaticoduodenectomy for Periampullary Cancer and Risk Factors: A Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- Risk factors relate to pancreatic fistula
研究概览
简要总结
Patients who are diagnosed with periampullary cancer will be performed pancreaticoduodenectomy with 3 types of pancreatic-jejunal anastomosis reconstructions. The investigator will analysis the complication of pancreatic fistula about: the clinical symptoms, laboratory test changing, intra-operative morphology, the risk factors
详细描述
This study will conduct at two centers at the same time: University of Medicine and Pharmacy Center and Cho Ray Hospital. The patients will be consulted to participate to this research from September, 2021 to April, 2023.
Plan for conducting study:
- The investigator consults and gets consensus form of the patient with periampullary cancer.
- The patient will be prepared for pancreaticoduodenectomy: pre-operative laboratory test, pre-operative biliary drainage, anesthetic checking.
- The investigator collected intr-operative data, include type of pancreatic-duodenal reconstruction, type of pancreatic duct's drainage, quantity of blood loss and blood transfusion.
- The investor follows post-operative period.
- If there are pancreatic fistula appear, the investigator will collect the clinical signs, laboratory test changing, re-operative morphology.
- The investigator analysis the risk factors of pancreatic fistula.
Data analysis:
- To determine the incidence of pancreatic fistula, the morphology of pancreatic fistula, descriptive statistics will be used.
- To determine the risk factors of pancreatic fistula, logistic regression will be used.
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 with periampullary cancer and can be performed pancreaticoduodenectomy.
- •Pancreaticoduodenectomy with one of three types of pancreatic - duodenal anastomosis reconstructions.
排除标准
- •The patient does not consent to participate in the study
结局指标
主要结局
Risk factors relate to pancreatic fistula
时间窗: 30 days of post-operative period
The investigator will analyse some of the risk factors that relate to pancreatic fistula, including pre-operative factors (BMI, albumin, bilirubin, biliary drainage), intra-operative elements (pancreatic duct 's diameter, pancreatic textile, blood transfusion, portal vein reconstruction), and post-operative factors (abdominal drainage's volume, fluid amylase, abdominal abscess..). The investigator will use the multivariable regression model to determine the risk factors (p-value\<0.05)
Pancreatic fistula
时间窗: 30 days of post-operative period
The investigator will describe the day that appears pancreatic fistula, the clinical symptoms, intra-operative morphology if being indicated to re-operate. The measurement tool to diagnose pancreatic fistula is fluid amylase on the POD3 (fluid amylse is 3 times compared to serum's amylase)
次要结局
- Short-term result in treatment of post-operative pancreatic fistula(30 days of post-operatvive period)
研究者
Vo Truong Quoc
Doctor, Lecturer, Surgeon
University of Medicine and Pharmacy at Ho Chi Minh City