To Investigate The Difference of Complications and Short-term Prognosis Between Laparoscopic and Open Pancreaticoduodenectomy in Patients With Pancreatic Cancer Based on a Special Disease Cohort Database
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Overall survive
研究概览
简要总结
Main objective: This project intends to design a simulated RCT project and clinically relevant RCT study to target, selecting the study titled "Short-Term outcomes Following Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Pancreatic Ductal Adenocarcinoma: A Randomized Clinical Trial (Short-term Outcomes of Laparoscopic versus Open Pancreaticoduodenectomy in Patients with Pancreatic Ductal Adenocarcinoma)", use the cases in the Pancreatic Cancer Special Disease Cohort Database, compare the differences in complications and short-term prognosis between patients with pancreatic cancer after laparoscopic and open pancreaticoduodenectomy, investigate the efficacy and safety of laparoscopic pancreaticoduodenectomy, and provide the basis and reference of real-world data for clinical relevant studies. Secondary objective: To predict the incidence of postoperative complications and short-term outcomes of pancreatic cancer patients by comparing the difference of complications and short-term prognosis between laparoscopic and open pancreaticoduodenectomy, and to improve the treatment power of patients scheduled for surgery and postoperative patients.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 years old, with no gender limit;
- •Histologically confirmed or clinically diagnosed as pancreatic cancer by MDT (multidisciplinary team), without histopathological evidence;
- •Patients may receive LPD or OPD according to the MDT evaluation;
- •Patients understand and are willing to comply with the trial;
- •Signed written informed consent before patient enrollment;
- •Patients who meet the clinical guidelines for intent to treat.
- •Those who met each of the above criteria were included in the study.
排除标准
- •Patients with distant metastasis found before or during surgery, including peritoneal, liver, distant lymph node metastasis, and other organ involvement;
- •Patients who need pancreatic neck or pancreatic tail, total pancreatic resection or other palliative surgery;
- •Preoperative anesthesia ASA score of 4 points;
- •A history of other malignant tumors;
- •Pregnant or lactating women;
- •Patients with severe mental disorders;
- •MDT evaluates patients with vascular invasion and requiring vascular resection based on abdominal imaging data;
- •Patients who have participated in other clinical trials within 3 months. Those who meet any of the above criteria were not included in the study.
结局指标
主要结局
Overall survive
时间窗: from the day after surgery to 3 years
complication
时间窗: during the days Postoperative up to 1 year
any possible symptoms caused by surgery
次要结局
未报告次要终点
研究者
Zhijun Bao
Dean
Fudan University