Laparoscopic Versus Open Pancreatoduodenectomy Following Neoadjuvant Chemotherapy for BRPC (NCT04855331) | Clinical Trial Compass
UnknownNot Applicable
Laparoscopic Versus Open Pancreatoduodenectomy Following Neoadjuvant Chemotherapy for BRPC
China120 participantsStarted 2021-04-15
Plain-language 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
Who can participate
Age range18 Years – 80 Years
SexALL
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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 (biologically borderline resectable), anatomically borderline resectable pancreatic cancer (BRPC) with good physical condition;
* Receive at least 2 cycles of neoadjuvant chemotherapy before radical surgeryï¼›
* 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 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 …