Minimally Invasive Versus Open Radical Pancreatectomy After Neoadjuvant Chemotherapy for Pancreatic Cancer

  • STATUS
    Recruiting
  • End date
    Dec 18, 2025
  • participants needed
    160
  • sponsor
    Fudan University
Updated on 18 September 2021

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

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.

Details
Condition Pancreatic Ductal Adenocarcinoma
Treatment Minimally invasive radical pancreatectomy, Open radical pancreatectomy
Clinical Study IdentifierNCT04855331
SponsorFudan University
Last Modified on18 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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, borderline resectable pancreatic cancer (BRPC) with good physical condition, and locally advanced pancreatic cancer (LAPC) with tolerable general condition
Receive at least 2 cycles of neoadjuvant chemotherapy before radical surgery
After neoadjuvant chemotherapy, the patient can be further treated by minimally invasive 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

Exclusion Criteria

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 in RPC or BRPC patients during neoadjuvant chemotherapy. After neoadjuvant chemotherapy, LAPC patients failed reach the standard of minimally invasive surgery
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