A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Trial of Octreotide Microspheres for Preventing Pancreatic Fistula After Distal Pancreatectomy
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 230
- 主要终点
- Incidence of CR-POPF at 60 days postoperatively
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Octreotide Microspheres
Octreotide microspheres (Youyuan), 30 mg, intramuscular injection; administered 7 days before surgery.
干预措施: Octreotide Microspheres (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of CR-POPF at 60 days postoperatively
时间窗: 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).
次要结局
- Length of hospital stay(up to 60 days)
- Incidence and grading of adverse events (AEs) (NCI-CTCAE v5.0).(up to 60 days)
- Incidence of biochemical leak(up to 60 days)
- Proportion of chyle leakage, hemorrhage, intra-abdominal infection, and delayed gastric emptying at 60 days postoperatively(up to 60 days)
- Mortality rate at 60 days postoperatively(up to 60 days)
- Proportion of patients requiring rescue therapy(up to 60 days)