Pancreatic Fistula
Conditions
Interventions
Treatment group:Octreotide microspheres (Youyuan), 30 mg, intramuscular injection
Control group:Control group: Placebo (normal saline)
a single dose was administered 7 days before surgery.
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Subjects voluntarily participate in this study and sign the informed consent form; 2.Age >=18 and <=80 years old, both males and females are eligible; 3.Preoperative imaging assessment indicates the corresponding disease is surgically resectable; 4.Planned to undergo distal pancreatectomy; 5.Female subjects of childbearing potential must agree to use reliable methods of contraception from the time of signing the informed consent form until at least 120 days after administration of the study drug. A negative HCG test result within 7 days prior to initiating study treatment is required, and they must not be lactating; 6.Male subjects with partners of childbearing potential must agree to use reliable methods of contraception from the time of signing the informed consent form until at least 120 days after administration of the study drug; during the same period, male patients must also agree not to donate sperm.
Exclusion criteria
Exclusion criteria: 1.Cirrhosis or chronic active hepatitis; 2.Presence of malabsorption syndrome, short bowel syndrome, or choleretic diarrhea that cannot be effectively controlled; 3.Acute cholecystitis; 4.Uncontrolled infection, or history of immunodeficiency, including a positive HIV test; 5.International Normalized Ratio (INR) >1.5, or use of medication affecting prothrombin time (PT) or activated partial thromboplastin time (APTT); 6.Patients scheduled for total pancreatectomy; 7.History of pancreatic resection surgery; 8.Concurrent severe cardiac, pulmonary, hepatic, or renal disease making the patient unfit for surgery; 9.Previous treatment with long-acting somatostatin analogues; treatment with somatostatin or short-acting somatostatin analogues within 5 half-lives; 10.Known allergy to somatostatin or its analogues; 11.Current participation in another clinical trial, except for observational, non-interventional studies or the follow-up period of an interventional study; 12.Any condition that, in the investigator’s judgment, may pose a risk to the subject from receiving the study drug, or may interfere with the evaluation of the study drug, subject safety, or interpretation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of clinically relevant postoperative pancreatic fistula (CR-POPF) at 60 days postoperatively (according to the 2016 International Study Group on Pancreatic Surgery [ISGPS] criteria).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of biochemical leak (according to the 2016 ISGPS criteria);Proportion of chyle leakage, hemorrhage, intra-abdominal infection, and delayed gastric emptying at 60 days postoperatively (according to the 2022 Guidelines for Prevention and Management of Common Post-pancreatectomy Complications);Mortality rate at 60 days postoperatively;Proportion of patients requiring rescue therapy (including administration of somatostatin or short-acting octreotide, abdominal paracentesis or drainage catheter placement, anti-infection treatment, endoscopic therapy, angiographic embolization, abdominal hemostasis, etc.);Length of hospital stay;Duration of catheter/drain placement; | — |
Countries
China
Contacts
Public ContactLiang Liu
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed