Pancreatic fistula after pancreaticoduodenectomy
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Participants must meet the following criteria in order to enter this study: 1. The subjects voluntarily joined this study and signed an informed consent form; 2. Age = 18 years old and = 75 years old, regardless of gender; 3. Pancreaticoduodenectomy surgery is required; 4. Preoperative imaging evaluation indicates that the corresponding disease can be surgically removed; 5. The American Society of Anesthesiologists (ASA) grades I-III; 6. Female subjects with fertility must agree to use reliable methods of contraception for at least 120 days from signing the informed consent form until the study drug is administered, and HCG tests must be negative within 14 days before the start of study treatment and must be non lactating; 7. For male subjects whose partners are fertile women, they must agree to use reliable methods of contraception for at least 120 days from signing the informed consent form until the study drug is administered; Male patients must also agree not to donate sperm during the same time period.
Exclusion criteria
Exclusion criteria: Participants will not be admitted to the study if they have had any of the following: 1. Within 5 years or simultaneously with malignant tumors other than the pancreas and duodenum. Cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc. can be included in the group; 2. Have malabsorption syndrome, short bowel syndrome, or biliary diarrhea that cannot be effectively controlled; 3. QTc>450ms; 4. Liver cirrhosis and chronic active hepatitis; 5. Acute cholecystitis; 6. Have an infection that is difficult to control, or have a history of immunosuppression, including a positive HIV test; 7. International Normalized Ratio (INR) >1.5, or are using drugs that affect prothrombin time (PT) or activated partial thromboplastin time (APTT); 8. White blood cell count<3×109/L, platelet count<100×109/L; 9. Patients undergoing palliative surgery for malignant tumors; 10. Patients undergoing total pancreatectomy; 11. History of pancreatic resection surgery; 12. Complicated with serious heart, lung, liver, kidney and other diseases, unable to tolerate surgery; 13. Previously received treatment with long-acting somatostatin analogues; Within 5 half-lives of treatment with somatostatin or short-acting somatostatin analogues; 14. Known allergy to somatostatin or its analogues; 15. Participating in another clinical study, unless it is an observational, non-interventional clinical study or the follow-up period of an interventional study; 16. Any condition that the investigator believes there may be a risk of receiving the study drug treatment, or that would interfere with the evaluation of the study drug, subject safety, or the interpretation of the study results.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The incidence of complications at 60 days after surgery;Mortality of complications at 60 days after surgery;Proportion of remedial treatment;Length of hospital stay;Time of extubation 60 days after surgery; | — |
Primary
| Measure | Time frame |
|---|---|
| The incidence of CR-POPF at 60 days after surgery; | — |
Countries
China
Contacts
Public ContactXiaoyu Yin
The First Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed