Pancreatic Solid Lesions
Conditions
Interventions
treatment group:ceftriaxone
control group:Blank
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Sign the informed consent The pharmacodynamic effects and risks predicted by the objective content of the study were fully explained and understood 2) Target population A) Patients with pancreatic solid lesions requiring EUS-FNA; B) Patients with good compliance can voluntarily comply with relevant regulations of this study for treatment and follow-up; C) Physical condition ECOG score 0-1; D) No antibiotics were used for any other indication within 5 days prior to surgery; E) No other diseases requiring antibiotics for endoscopic invasive surgery; F) No contraindications for the use of ceftriaxone; G) No serious abnormal blood system, cardiopulmonary, liver, kidney function or immune deficiency; 3) No abnormality in physical examination and laboratory examination results; a) Hematological dysfunction was defined as: i) Absolute count of neutrophils (ANC) >= 1.5 x 10^9/L; ii) Platelet count (PLT) >= 80 x 10^9/L; iii) hemoglobin (Hb) >= 90g/L. b) Abnormal liver function was defined as: i) Total bilirubin (TBil) level: less than 1.5 times of the upper limit of normal value (ULN); ii) AST and ALT: less than 2.5 times of ULN, and less than 5 times of ULN in the presence of liver metastases. c) definition of renal dysfunction: serum creatinine: less than 1.5 times of ULN, or the calculated creatinine clearance rate: more than 50ml/min. d) Coagulation abnormalities defined as: international standardized ratio (INR): less than 1.5 times of the ULN, and the prothrombin time (PT) or activated partial thromboplastin time (aPTT): less than 1.5 times of ULN, unless the subject is receiving anticoagulant therapy. 4) Hepatitis B surface antigen (HBsAg) positive, and hepatitis B virus DNA (HBV-DNA) titer detection in peripheral blood less than 1 x 10^3 copy number /L;If HBsAg positive and the number of copies /L of HBV-DNA is more than 1 x 10^3 in the peripheral blood, the patient is eligible for inclusion if the investigator believes that the subject's chronic hepatitis B is stable and does not increase the subject's risk. 5) Age and reproductive status. a) Men and women between the ages of 18 to 75 years; b) Subjects of childbearing age must agree to use effective contraception during the study period; c) The woman must be non-pregnant and non-breast feeding.
Exclusion criteria
Exclusion criteria: 1) Use antibiotics for any other indication within 5 days before surgery; 2) Contraindications for the use of ceftriaxone; 3) Other diseases requiring antibiotics for endoscopic invasive surgery; 4) The patient is unable or unwilling to give written informed consent; 5) Patients with existing risk factors such as stent implantation or choledochojejunostomy. 6) Medical history and complications A) Uncontrolled severe medical conditions that the investigator believes will affect the subject's ability to receive treatment under the study protocol, such as combined severe medical conditions, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, etc.; B) long-term systemic sex hormone (equivalent to > 10mg prednisone/day) or any other form of immunosuppressive therapy; C) dementia, change of mental state or any mental illness that would prevent understanding or informed consent or the completion of a questionnaire; 7) Hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV) antibody positive. 8) Active infections requiring systemic treatment. 9) Researchers believe that there are other conditions that are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood routine examination;CRP; | — |
Countries
China
Contacts
Public ContactXianjun Yu
Fudan University Shanghai Cancer Center
Outcome results
None listed