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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Laparoscopic pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer.
Open pancreatoduodenectomy following neoadjuvant chemotherapy for borderline resectable pancreatic cancer.
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGPostoperative complications
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.
Time frame: 90 days after the surgery
Length of stay
The length of hospital stay from the end of surgery to discharge or death. The length of hospital stay for readmission after discharge is not included.
Time frame: 90 days after the surgery
Operation time
The time from the beginning to the end of the surgery.
Time frame: 1 day
R0 resection rate
Postoperative pathology confirmed that there were no tumor cells in the tissue within 1 mm from the surgical margin.
Time frame: 30 days after the surgery
The 90 days readmission rate
The rate of rehospitalization within 90 days after surgery due to aggravation.
Time frame: 90 days after the surgery
The 90 days mortality rate after operation
The mortality within 90 days after surgery.
Time frame: 90 days after the surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.