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Clinical Trial Summary

The aim of this study is to evaluate the safety and effectiveness of minimally invasive versus open radical pancreatectomy after neoadjuvant chemotherapy for pancreatic ductal adenocarcinoma

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04855331
Study type Interventional
Source Fudan University
Contact Xianjun Yu, MD, PhD
Phone +86-13801669875
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date May 2021
Completion date December 2025

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