Mechanistic Study on the Protective and Regenerative Effects of Spirulina in Hepatectomy-Related Liver Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Alanine Aminotransferase (ALT) Level
研究概览
简要总结
The goal of this clinical trial is to learn if spirulina can help protect the liver and promote recovery after partial hepatectomy (surgery to remove part of the liver). It will also learn about the safety of spirulina in patients undergoing liver surgery.
The main questions it aims to answer are:
Does spirulina help improve liver function after surgery? Does spirulina promote liver regeneration and reduce inflammation? What side effects, if any, occur when participants take spirulina? Researchers will compare spirulina tablets to a placebo (a look-alike tablet that contains no spirulina) to see if spirulina helps protect the liver and support recovery after surgery.
Participants will:
Take spirulina or placebo tablets daily for 3 weeks before and 3 weeks after surgery.
Provide blood and stool samples before and after treatment. Allow the collection of a small piece of liver tissue (from surgical waste) for analysis.
Have regular clinic visits for checkups, blood tests, and safety monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with cholangiocarcinoma (bile duct cell carcinoma).
- •Child-Pugh Class A liver function.
- •Planned to receive neoadjuvant therapy with gemcitabine + oxaliplatin, combined with lenvatinib and a PD-1 inhibitor, followed by anatomical hemihepatectomy (remaining liver volume > 40%).
- •Age 18-75 years, male or female. Willing and able to comply with the study protocol, including oral administration of spirulina or placebo for 3 weeks before and 3 weeks after surgery.
- •Voluntarily agrees to participate and signs written informed consent.
- •Has had no acute illness or significant symptom worsening within 4 weeks before enrollment.
排除标准
- •Presence of severe comorbidities (e.g., uncontrolled cardiovascular, respiratory, renal, or hematologic diseases).
- •Known allergy to spirulina or its components.
- •Concurrent malignant tumors other than the target disease.
- •History of previous liver resection surgery.
- •Severe psychiatric disorders that could affect compliance or the ability to provide informed consent.
结局指标
主要结局
Change in Alanine Aminotransferase (ALT) Level
时间窗: Day 0 (pre-treatment, ~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery)
Serum ALT will be measured at baseline and after the 6-week perioperative intervention. The outcome is the change from baseline compared between spirulina and placebo groups.
Change in Aspartate Aminotransferase (AST) Level
时间窗: Day 0 (~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery)
Serum AST will be measured at baseline and after the intervention. The analysis compares change from baseline between study arms.
Change in Total Bilirubin (TBIL) Level
时间窗: Day 0 (~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery)
Serum TBIL will be measured pre- and post-intervention. The change from baseline will be compared between groups.
次要结局
- Change in Serum Inflammatory Cytokine Concentrations(Day 0 (~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery))
- Change in Gut Microbial Species Abundance Measured by Fecal Metagenomic Sequencing(Day 0 (~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery))
- Gene Expression Profiles from Liver Tissue Assessed by Single-cell and/or Bulk Transcriptomic Sequencing(During liver surgery (partial hepatectomy))