Efficacy and Safety of Octreotide in Laparoscopic Hepatectomy Surgery: Effect on Blood Loss, Need for Vasoactive Drugs, Transfusion Requirements.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Incidence on intraoperative bleeding.
研究概览
简要总结
The goal of this double-blind clinical trial is to compare the efficacy of octreotide versus placebo in laparoscopic hepatectomy surgery in patients diagnosed with resectable hepatocarcinoma or liver metastases.
The main questions it aims to answer are:
- Decrease in intraoperative bleeding measured in ml of blood lost.
- Decrease in the need for blood transfusion and use of intraoperative vasoactive drugs.
Participants will receive octreotide or placebo after signing the informed consent form.
详细描述
The drug will be administered during surgery, after anesthetic induction, and will be withdrawn at the end of surgery before leaving the operating room.
The patient will not receive any visit or require the performance of any other additional tests that are performed in the usual clinical practice. The monthly follow-up will coincide with the medical check-up and control analytical data will be taken. Subsequently, an attempt will be made to contact with the patient 3 months after surgery.
The duration of participation of each participant in the trial will therefore be about 3 months after surgery.
The intervention group will receive a loading dose of octreotide (100 mcgr) diluted in 100 ml of SSF to be given in half an hour and after that a continuous perfusion of 25 mcgr/h will be started until the end of the surgery.
The pharmaceutical form to be used is Sandostatin.
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
- Double (Participant, Investigator)
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
- •Patients diagnosed with hepatic lesions who are going to undergo hepatectomy via laparoscopy.
- •The patient must be between 18 and 80 years old.
- •The patient, or his/her representative, has given his/her consent to participate in the study.
- •The patient must, in the opinion of the investigator, be able to comply with all the requirements of the clinical trial.
- •The patient must not be allergic to the drug.
排除标准
- •History of hypersensitivity to the drug to be administered.
- •Children under 18 years of age.
- •Urgent intervention.
- •Intervention performed in an open manner (not laparoscopic).
- •Patient's refusal to participate in the study.
- •Contraindication to receive octreotide.
- •Women of childbearing age (those women who are in the period between menarche and menopause). Having to present a negative pregnancy test to take part in the study.
- •Pregnant or lactating women, given the absence of studies of this drug in this patient profile.
研究组 & 干预措施
Treatment arm (octreotide)
This patient will receive the treatment: Octreotide charge 100 mcgr + continuous infusion during the surgery 25 mcgr/h
干预措施: Octreotide (Drug)
Placebo arm (saline solution)
This patient will receive physiologic saline solution at the same infusion
干预措施: Placebo (Other)
结局指标
主要结局
Incidence on intraoperative bleeding.
时间窗: During the time the surgery lasts.
Decrease in intraoperative bleeding measured in ml of blood lost during laparoscopic liver resection surgery via laparoscopy.
次要结局
- Rate of postoperative complications(Up to 90 days)
- Rate of intraoperative hemodynamic stability.(During the time the surgery lasts.)
- Number of patients with vasoactive use.(During the time the surgery lasts.)
- Incidence of intraoperative transfusion.(During the time the surgery lasts.)
- Incidence on the improvement of hepatic function(Up to 90 days)