Octreotide Microspheres for Preventing Pancreatic Fistula

Официальное название

A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Trial of Octreotide Microspheres for Preventing Pancreatic Fistula After Distal Pancreatectomy

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Octreotide Microspheres
  Octreotide Microspheres: 30mg, intramuscular injection, administered 7 days before surgery
• Препарат Placebo
  Control group: Placebo (normal saline), administered 7 days before surgery.

Первичные конечные точки

• Incidence of CR-POPF at 60 days postoperatively [Срок оценки: up to 60 days]

Вторичные конечные точки (6)

• Incidence of biochemical leak [Срок оценки: up to 60 days]
• Proportion of chyle leakage, hemorrhage, intra-abdominal infection, and delayed gastric emptying at 60 days postoperatively [Срок оценки: up to 60 days]
• Mortality rate at 60 days postoperatively [Срок оценки: up to 60 days]
• Proportion of patients requiring rescue therapy [Срок оценки: up to 60 days]
• Length of hospital stay [Срок оценки: up to 60 days]
• Incidence and grading of adverse events (AEs) (NCI-CTCAE v5.0). [Срок оценки: up to 60 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07479784 · B2026-051R

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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