Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Pancreatic Ductal Adenocarcinoma
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

In recent years, the incidence of pancreatic ductal adenocarcinoma (PDAC) has been increasing in the world. It has become the fourth leading cause of cancer death, and seriously threatens human life. The surgical resection rate of PDAC is very low, only about 15% - 20% of the patients can receive su...

In recent years, the incidence of pancreatic ductal adenocarcinoma (PDAC) has been increasing in the world. It has become the fourth leading cause of cancer death, and seriously threatens human life. The surgical resection rate of PDAC is very low, only about 15% - 20% of the patients can receive surgical treatment at the first visit. But at present, surgical resection is still the only treatment that can make the PDAC patients survive for a relative long time. (CA Cancer J Clin. 2016;66(1):7) With the application of neoadjuvant chemotherapy in clinical practice, the treatment concept of PDAC has changed significantly. A growing number of studies show that neoadjuvant chemotherapy can significantly improve the radical resection (R0) rate of PDAC patients, and thus improve the prognosis (J Clin Oncol. 2017;35(5):515; J Surg Oncol. 2019;120(6):976). Currently, according to the latest edition of the National Comprehensive Cancer Network (NCCN) guidelines, patients with resectable pancreatic cancer (RPC) with high risk factors, borderline resectable pancreatic cancer (BRPC) with good physical condition, and locally advanced pancreatic cancer (LAPC) with tolerable general condition, should receive neoadjuvant chemotherapy. With the development of pancreatic surgery, the mortality has decreased from 30% to 3-5%. Minimally invasive technique has the advantages of less intraoperative bleeding, less postoperative pain, less postoperative complications and relatively high cost-effectiveness. In other abdominal tumors, such as gastric and colorectal cancer, minimally invasive technique has been recommended as the first choice for radical operation (Gastroenterol Res Pract, 2017,2017:9278469; Surg Clin North Am, 2017,97(3):54). Minimally invasive pancreatic surgery is mainly composed of minimally invasive pancreatoduodenectomy (MIPD) and minimally invasive distal pancreatectomy (MIDP). With the progress of surgical technique, especially the maturity of laparoscopic or robotic vascular resection and reconstruction, MIPD becomes safe and feasible, and has been carried out in large pancreatic surgery centers. On the other hand, MIDP is the main indication of minimally invasive pancreatic surgery because it does not need digestive tract reconstruction, has no complex anastomosis, and involves less large vessels. Compared with open pancreatic surgery, MIDP has the advantages of less intraoperative bleeding and faster postoperative recovery, and there was no significant difference in the incidence of pancreatic fistula, total complication rate and mortality (Ann Surg. 2019;269(1):2; Updates Surg. 2020;72(2):387). Neoadjuvant chemotherapy can help to reduce tumor stage, alleviate vascular invasion, improve R0 resection rate, control tumor micro-metastasis and reduce tumor recurrence and metastasis risk. With the recommendations of clinical guidelines, patients with PDAC receiving neoadjuvant chemotherapy is increasing. For these patients, how to choose the further surgical strategy and whether minimally invasive surgery is safe and effective compared with open surgery have not been reported. Therefore, we designed this multicenter randomized controlled trial to assess the safety and effectiveness of minimally invasive versus open radical pancreatectomy after neoadjuvant chemotherapy for PDAC. This study will provide high-level evidence-based medicine for the choice of surgical strategy for PDAC after neoadjuvant chemotherapy.

Tracking Information

NCT #
NCT04855331
Collaborators
  • The Third Affiliated Hospital of Soochow University
  • Huadong Hospital
  • Nanfang Hospital of Southern Medical University
  • Zhujiang Hospital
  • The First Affiliated Hospital of University of South China
  • Qilu Hospital of Shandong University
  • West China Hospital
  • The Affiliated Hospital of Xuzhou Medical University
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Investigators
Principal Investigator: Xianjun Yu, MD, PhD Fudan University