Factors Influencing the Occurrence of Pancreatic Fistula After Minimally Invasive Pancreatic Enucleation and Predictive Models: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Incidence of Clinically Relevant Postoperative Pancreatic Fistula
研究概览
简要总结
Patients suffering from postoperative pancreatic fistula (POPF) after minimally invasive enucleation (MIEN) show a characteristic pattern of longer duration and milder symptoms, which is different from pancreatic fistula after standard pancreatectomy. This study aimed to analyze the factors influencing clinically-relevant POPF (CR-POPF) after MIEN, investigate and develop a personalized predictive model for accurate prediction of CR-POPF.
详细描述
Minimally invasive enucleation (MIEN) has been widely used in managing benign and low-grade malignant pancreatic tumors, showing better protection of pancreatic function and better long-term outcomes compared to standard pancreatectomy.
However, the incidence of postoperative pancreatic fistula (POPF) after MIEN is higher compared to standard resection, mainly since a large part of the pancreatic wound is exposed, and the main pancreatic duct may be exposed or injured, etc. POPF is the most important postoperative complication, and it has become a major constraint to the conduct of pancreatic MIEN.
Although risk factors and predictive models for POPF in standard pancreatic surgery have been reported in the past, no predictive models have been reported specifically for MEN. With the increasing adoption of MIEN, there is an urgent need for a predictive model to guide the treatment and prognosis of POPF. Therefore, this study aims to conduct a cohort study, with data prospectively collected and retrospectively analyzed. The result of this study will provide a valuable reference for the development and application of MIEN.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years, regardless of gender.
- •Benign or low-grade malignant tumor of the pancreas.
- •Patients evaluated according to guidelines that indicate a need for surgery or a strong request for surgery.
- •Feasibility of performing minimally invasive pancreatic tumor enucleation based on preoperative imaging evaluation.
- •Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Willingness to comply with the follow-up programme of the study and other protocol requirements.
- •Voluntary participation and signed informed consent.
排除标准
- •Concurrent presence of other malignant tumors.
- •Intraoperative frozen pathology or postoperative pathology indicating the tumor to be malignant, requiring oncological resection instead.
- •Severe impairment of cardiac, hepatic, or renal function (e.g., NYHA class 3-4 heart failure, ALT and/or AST levels exceeding three times the upper limit of normal, creatinine levels exceeding the upper limit of normal).
- •Missing data due to patient loss of followup, etc.
结局指标
主要结局
Incidence of Clinically Relevant Postoperative Pancreatic Fistula
时间窗: Within 90 days after surgery.
Clinically Relevant Pancreatic Fistula including Grade B fistulas, which require treatment beyond simple drainage, as well as Grade C fistulas.
次要结局
- Perioperative complication rate according to the Clavien-Dindo classification(Within 90 days after surgery.)
研究者
Xian-Jun Yu
President of Fudan University Shanghai Cancer Center
Fudan University