Status:
UNKNOWN
Laparoscopic Versus Open Pancreatoduodenectomy Following Neoadjuvant Chemotherapy for BRPC
Lead Sponsor:
Fudan University
Collaborating Sponsors:
The Third Affiliated Hospital of Soochow University
Qilu Hospital of Shandong University
Conditions:
Borderline Resectable Pancreatic Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04855331
Start Date
April 15 2021
End Date
December 1 2025
Last Update
May 9 2023
Active Locations (1)
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1
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032