Pancreatic cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Since the start of the study, patients who have been admitted to the Department of Pancreatic Surgery, Huashan Hospital, Fudan University, are diagnosed with pancreatic cancer; 2. The age of the patient is aged 18 to 75 years, and has full capacity for civil conduct, regardless of gender; 3. The patients tumor originated in the head, neck, or body of the pancreas, and the preoperative evaluation concluded that if pancreaticoduodenectomy is performed, the margin of the pancreas during the operation may be positive (R1/R2 resection) or the distal pancreas after R0 resection of the tumor Patients who cannot complete the pancreas-jejunum anastomosis and need to undergo full pancreatectomy; or the tumors of the head, neck, or body of the pancreas, combined with benign/boundary lesions of the tail of the pancreas that require surgical intervention, and all need to be performed Patients undergoing pancreatectomy; 4. The patient has not received neoadjuvant therapy before surgery, and the preoperative assessment is resectable/borderline resectable pancreatic cancer (that is, the clinicopathological staging is cT1-3NxM0); 5. The postoperative pathological diagnosis of the patient is pancreatic ductal adenocarcinoma (if it is combined with pancreatic tail lesions, the pathological diagnosis must be pancreatic benign/boundary disease); 6. The patient has fully understood the content and purpose of this study, and voluntarily participates in this study, willing to cooperate with the researchers to complete the follow-up, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients whose pancreatic tumors involve other nearby organs (including but not limited to adrenal glands, colon, stomach wall, etc.) and need to undergo combined resection of other organs at the same time; or patients whose tumors are found to be unable to be removed radically during the operation. 2. Patients who have received neoadjuvant chemotherapy for pancreatic cancer, or have received chemotherapy or abdominal radiotherapy with a history of malignant tumors; 3. In addition to pancreatic tumors, patients who also have other malignant tumors at the same time; 4. Patients with a history of various types of diabetes (except gestational diabetes) before the operation, and the course of the disease is more than 1 year; or patients with diabetes who need insulin treatment; 5. Patients who are using anticoagulant drugs and antiplatelet aggregation drugs (including but not limited to: warfarin, clopidogrel, aspirin, etc.), and the drug withdrawal time is less than 2 weeks; 6. Patients who use immunosuppressive agents or glucocorticoids for a long time; 7. Combined moderate-severe systemic disease, or preoperative examination found the following conditions, including: (1) Heart function NYHA Class III-IV, or a history of acute coronary syndrome in the past 6 months; (2) Patients who have a history of COPD or asthma, and currently need to use inhaled or oral drugs for long-term control; (3) Child-Pugh score of liver function B-C, or ALT, AST > 3 times the upper limit of normal, or total bilirubin (TBIL) >=100mmol/L; (4) CKD stage 4-5, or preoperative blood creatinine is greater than the upper limit of normal reference; (5) Abnormal coagulation function: PT and APTT are 1.5 times higher than the upper limit of normal reference, INR higher than the upper limit of normal reference value, or platelet count <= 50x10^9/L; (6) Patients with various blood system diseases other than mild anemia; (7) Autoimmune diseases (excluding autoimmune pancreatitis and IgG4-related autoimmune diseases); (8) Anesthesia ASA grade III and above; (9) Cerebrovascular accidents such as stroke occurred within six months; (10) Patients who suffer from infectious diseases and the disease has not been effectively controlled, or who are in the active or infectious period; (11) Patients suffering from mental illness; 8. Patients with a history of obvious scars; 9. Patients who are currently pregnant or breastfeeding; 10. Patients who are currently participating in clinical research related to other drugs or medical devices; 11. Other investigators consider it inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Perioperative glycemic status;Postoperative long-term glycemic status;Incidence of perioperative complications; | — |
Countries
China
Contacts
Huashan Hospital, Fudan University