Octreotide Microspheres for Preventing Pancreatic Fistula
230 participantsStarted 2026-04-01
Plain-language summary
This study is a randomized, double-blind, placebo-controlled, multicenter phase III clinical trial designed to evaluate the efficacy and safety of octreotide microspheres in preventing pancreatic fistula after distal pancreatectomy.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Subjects voluntarily participate in this study and sign the informed consent form;
* Age ≥18 and ≤80 years old, both males and females are eligible;
* Preoperative imaging assessment indicates the corresponding disease is surgically resectable;
* Planned to undergo distal pancreatectomy;
* 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;
* 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:
* Cirrhosis or chronic active hepatitis;
* Presence of malabsorption syndrome, short bowel syndrome, or choleretic diarrhea that cannot be effectively controlled;
* Acute cholecystitis;
* Uncontrolled infection, or history of immunodeficiency, including a positive HIV test;
* International Normalized Ratio (INR) \>1.5, or use of medication affecting prothrombin time (PT) or activated partial thromboplastin time (APTT);
* Patients scheduled for total pancreatectomy;
* History of pancreatic resection surgery;
* Concurrent severe ca…