Octreotide Microspheres for Preventing Pancreatic Fistula
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Octreotide Microspheres, Placebo.
- Who it may be relevant to
- Registry conditions: Pancreatic Fistula. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Trial of Octreotide Microspheres for Preventing Pancreatic Fistula After Distal Pancreatectomy
Overview
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.
Detailed description
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. Participants will be enrolled and allocated, with approximately 230 individuals expected to participate in this study conducted across three different medical institutions.
Interventions
- Drug Octreotide Microspheres
Octreotide Microspheres: 30mg, intramuscular injection, administered 7 days before surgery - Drug Placebo
Control group: Placebo (normal saline), administered 7 days before surgery.
Primary outcome measures
- Incidence of CR-POPF at 60 days postoperatively [Time frame: up to 60 days]
Secondary outcome measures (6)
- Incidence of biochemical leak [Time frame: up to 60 days]
- Proportion of chyle leakage, hemorrhage, intra-abdominal infection, and delayed gastric emptying at 60 days postoperatively [Time frame: up to 60 days]
- Mortality rate at 60 days postoperatively [Time frame: up to 60 days]
- Proportion of patients requiring rescue therapy [Time frame: up to 60 days]
- Length of hospital stay [Time frame: up to 60 days]
- Incidence and grading of adverse events (AEs) (NCI-CTCAE v5.0). [Time frame: up to 60 days]
Eligibility criteria
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 cardiac, pulmonary, hepatic, or renal disease making the patient unfit for surgery;
- Previous treatment with long-acting somatostatin analogues; treatment with somatostatin or short-acting somatostatin analogues within 5 half-lives;
- Known allergy to somatostatin or its analogues;
- Current participation in another clinical trial, except for observational, non-interventional studies or the follow-up period of an interventional study;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07479784 · B2026-051R