Predictive Risk Factors for Postoperative Pancreatic Fistula After Pancreaticoduodenectomy for Malignancy.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of clinically relevant post operative pancreatic fistula
研究概览
简要总结
Pancreaticoduodenectomy (PD) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality. Postoperative pancreatic fistula (POPF) is the most common and clinically significant complication following PD. In this study, the investigators aim to determine the predictive risk factors for clinically related postoperative pancreatic fistula (CR-POPF) in the preoperative, intraoperative and postoperative period in patients that underwent PD. The total number of 100 participants expected to be included in this research who underwent PD between 2025 and 2026.
详细描述
Pancreaticoduodenectomy (PD) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality rates. Despite dramatic advancements in surgical techniques and perioperative management, reported morbidity and mortality rates following PD are 41.56% and 2.88%, respectively, which remain unsatisfactory. Postoperative pancreatic fistula (POPF) is the most common and clinically significant complication following PD. Therefore, accurate and timely prediction of POPF after PD is necessary to reduce secondary mortality from serious complications and optimize individual patient treatment decisions. This study aimed to determine the predictive risk factors for clinically related postoperative pancreatic fistula (CR-POPF) in the preoperative, intraoperative and postoperative period in patients that underwent PD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with resectable distal common bile duct carcinoma, periampullary carcinoma, duodenal carcinoma, and carcinoma of the head of the pancreas.
- •Patients meeting the curative treatment intent in accordance with clinical guidelines:
- •No evidence of metastasis.
- •Radiological non-involvement of superior mesenteric vein & portal vein.
- •American Society of Anesthesiologists (ASA) scores I & II.
- •Patients aged > 18 years.
- •Ability to understand and the willingness to sign a written informed consent document
- •Agreement to complete the study
排除标准
- •Unfit patients for surgery due to severe medical illness.
- •Inoperable patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs.
- •Irresectable tumors in diagnostic laparoscopy.
- •History of other malignant disease.
- •Pregnant or breast-feeding women.
- •Patients with serious mental disorders.
- •Patients with vascular invasion and requiring vascular resection as evaluated by the multidisciplinary team according to abdominal imaging data.
- •Pancreatoduodenectomy for other diagnosis like cystic lesions, benign tumors or chronic calcific pancreatitis
- •Patients refused to participate in the study.
研究组 & 干预措施
Clinically relevant postoperative pancreatic fistula
patients who developed clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy
干预措施: pancreaticoduodenectomy procedure (Procedure)
结局指标
主要结局
Incidence of clinically relevant post operative pancreatic fistula
时间窗: 10 days
A drainage fluid of any measurable volume with an amylase level more than three times the upper normal serum level on or after the 3rd postoperative day
次要结局
未报告次要终点
研究者
Saleh Khairy Saleh MD
Lecturer
Minia University