Study of Pancreatic Fistula and Bleeding Complication After Pancreaticoduodenectomy in Treatment Periampullary Cancer
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
- Pancreatic fistula
研究概览
简要总结
This multi-site study will be done across Hepatobiliary and Pancreatic Surgery Department at Cho Ray Hospital and University and Pharmacy Center. Patients who are diagnosed with periampullary cancer from August 2021 to August 2023 will be underwent pancreaticoduodenectomy. We will follow-up for their pancreatic fistula and bleeding complication and analysis some risk factors.
详细描述
The investigator will conduct this study at both site at the same time: Cho Ray Hospital and University and Pharmacy Center. The investigator will directly consult the patient to participate in the study, collect the preoperative information, intraoperative protocol and postoperative data. The investigator will statically analysis the incident of the morbidity (mainly for pancreatic fistula and bleeding), and invest some risk factors relating to those complications.
Plan for conducting the study:
- The patient diagnosed with periampullary cancer will be consulted with surgical method, operative risks, postoperative complications and agree to participate in the study. The patient signes a consent form to participate in the study.
- Pancreaticoduodenectomy will be performed according to the uniformity protocol of both hospitals: Cho Ray Hospital and University of Medicine and Pharmacy Center.
- Post-operative data will be collected and based on the general procedure.
Data analysis
- To determine the incidence of pancreatic fistula and bleeding, survival analysis will be used.
- To determine the association of risk factors with pancreatic fistula and bleeding, logistic regression was used, the value with p < 0.05 will be included in the multivariable regression model to determine the real risk factors.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with periampullary cancer meet the following criteria:
- •Possibility to perform pancreaticoduodenectomy based on preoperative imaging and intraoperative exploration.
- •The postoperative pathology is adenocarcinoma (of the ampulla of Vater, common bile duct, duodenum or pancreas)
排除标准
- •The patient has other organ's cancer beyond periampullary cancer.
- •Patient's medical conditions contraindicate for anesthesia.
- •The patient does not consent to participate in the study
结局指标
主要结局
Pancreatic fistula
时间窗: 90 post-operative days
Rate of post-operative pancreatic fistula, risk factors associate to pancreatic fistula
次要结局
- Bleeding complication(90 post-operative days)
研究者
Vo Truong Quoc
General Surgery Department, Principal Investigator, Clinical Professor
University of Medicine and Pharmacy at Ho Chi Minh City