Current partner codePEPTIDESDE
NCT07479784·Phase 3·INTERVENTIONAL

Octreotide Microspheres for Preventing Pancreatic Fistula

Status

Not yet recruiting

Phase

Phase 3

Enrollment

230

Locations

0

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    Mar 18, 2026

  2. Study start

    Apr 1, 2026

  3. Primary completion

    Dec 31, 2027

  4. Study completion

    Dec 31, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Mar 18, 2026

Outcomes

What the study measures.

Primary outcomes

Incidence of CR-POPF at 60 days postoperatively

Time frame · up to 60 days

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 outcomes

Incidence of biochemical leak

Time frame · up to 60 days

Incidence of biochemical leak at 60 days postoperatively(according to the 2016 ISGPS criteria).

Proportion of chyle leakage, hemorrhage, intra-abdominal infection, and delayed gastric emptying at 60 days postoperatively

Time frame · up to 60 days

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

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

Who can take part.

Minimum age
18 Years
Maximum age
80 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Octreotide.

Related PeptideStat pages

Put the record in context.

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