Laparoscopic Versus Open Pancreatoduodenectomy Following Neoadjuvant Chemotherapy for Borderline Resectable Pancreatic Cancer: An Multicenter Open-label Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Postoperative complications
研究概览
简要总结
The aim of this study is to evaluate the safety and efficacy of laparoscopic versus open pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer
详细描述
Pancreatic ductal adenocarcinoma (PDAC) is one of the most aggressive tumors with an increasing incidence and constitutes the fourth leading cause of cancer-related deaths. Radical resection remains the potential curative treatments for selected patients, and the Miami international evidence-based guidelines suggest that minimally invasive resection is feasible, safe, and oncologically equivalent for PDAC patients compared with open surgery. Furthermore, minimally invasive pancreatomy was associated with better overall and disease-free survival.
However, only 15% to 20% PDAC patients are eligible for upfront surgery at the time of initial diagnosis. For borderline resectable PDAC, studies have confirmed that neoadjuvant therapy can provide more oncological benefits than upfront surgery, such as improved rates of margin-negative resection and decreased incidence of lymph node metastases. Additionally, short-term neoadjuvant therapy has been shown to improve postoperative survival. These findings support the use of short-term neoadjuvant therapy in borderline resectable PDACs, as recommended by the National Comprehensive Cancer Network guidelines.
Neoadjuvant therapy can lead to severe fibrosis in the localized tumor tissue, which may hinder dissection and increase the risk of dangerous and bloody surgery. Furthermore, most anatomically borderline resectable PDACs have a large diameter and are in close proximity to major blood vessels, making the surgical procedure more complex and challenging. To date, there is insufficient evidence to determine the feasibility and safety of minimally invasive pancreatectomy compared to open surgery after neoadjuvant therapy.
This study aims to evaluate the safety and efficacy of laparoscopic pancreatoduodenectomy (LPD) versus open pancreatoduodenectomy (OPD) for borderline resectable PDAC following neoadjuvant chemotherapy (NACT) through a multicenter randomized controlled clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Before neoadjuvant chemotherapy, pancreatic ductal adenocarcinoma was confirmed by pathology;
- •According to the guidelines, neoadjuvant chemotherapy should be performed before surgery, including patients with resectable pancreatic cancer (RPC) with high risk factors (biologically borderline resectable), anatomically borderline resectable pancreatic cancer (BRPC) with good physical condition;
- •Receive at least 2 cycles of neoadjuvant chemotherapy before radical surgery；
- •After neoadjuvant chemotherapy, the patient can be further treated by laparoscopic or open surgery;
- •No obvious surgical contraindications, suitable for minimally invasive surgery;
- •ECOG score of preoperative physical condition was 0-1;
- •No history of preoperative pancreatitis;
- •Preoperative PET-CT or other imaging examination did not show distant metastasis;
- •The expected postoperative survival time was more than 3 months;
- •Be able to comply with research protocol, follow-up plan and other protocol requirements;
- •Voluntary participation and signed informed consent.
排除标准
- •Neoadjuvant chemotherapy is not suitable before operation according to the guidelines;
- •Invasion of adjacent organs, abdominal cavity or distant metastasis was found by introperative exploration;
- •Patients requiring total pancreatectomy;
- •Severe impairment of heart, liver and kidney function;
- •Patients with other malignancies or hematological diseases;
- •The patient is pregnant, planning to be pregnant or lactating；
- •Before surgery, anti-cancer therapy except neoadjuvant chemotherapy were performed, including interventional chemoembolization, ablation, radiotherapy and molecular targeted therapy;
- •Participants in other clinical trials;
- •Tumor progression occurred during neoadjuvant chemotherapy. After neoadjuvant chemotherapy, patients failed reach the standard of laparoscopic surgery.
结局指标
主要结局
Postoperative complications
时间窗: 90 days after the surgery
The specific postoperative complications of pancreatic surgery include postoperative pancreatic fistula, postoperative hemorrhage and gastroparesis. Other common postoperative complications include abdominal infection, incision nonunion and so on. The degree of complications was evaluated by Clavien-Dindo grading system.
次要结局
- Operation time(1 day)
- The 90 days mortality rate after operation(90 days after the surgery)
- Length of stay(90 days after the surgery)
- The 90 days readmission rate(90 days after the surgery)
- R0 resection rate(30 days after the surgery)
研究者
Xian-Jun Yu
President of Fudan University Shanghai Cancer Center
Fudan University