Could a simple injection stop pancreatic leaks after surgery?
NCT ID NCT07479784
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a drug called octreotide microspheres can prevent pancreatic fistula, a common and serious leak that can happen after part of the pancreas is removed. About 230 adults scheduled for this surgery will receive either the drug or a placebo. The goal is to see if the drug reduces the number of leaks within 60 days after the operation.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 230 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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