Protective Mechanisms of Phycocyanin in Partial Hepatectomy-Associated 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 Serum Aspartate Aminotransferase (AST) Level
研究概览
简要总结
The goal of this study is to find out whether phycocyanin, a natural protein from spirulina, can help protect the liver and support recovery in adults having part of their liver removed. The study will also look at whether phycocyanin is safe to take.The main questions are:
Does phycocyanin reduce liver injury after surgery? Does it help the liver grow back and recover? What side effects or medical problems happen while taking it?
Researchers will compare phycocyanin with a placebo, which looks similar but does not contain phycocyanin. About 30 people will take part. Each person will be randomly placed into one of the two groups, and neither the participants nor the researchers will know which treatment each person receives during the study.
Participants will:
Take 1.5 grams of phycocyanin or placebo every day for 3 weeks before surgery and 3 weeks after surgery Receive the usual care for liver surgery Give blood and stool samples before and after treatment Allow researchers to study a small piece of liver tissue removed during surgery Return for follow-up for up to 90 days after surgery
The samples will be used to check liver function, inflammation, gut bacteria, and changes linked to liver healing. Possible side effects include an allergic reaction or stomach discomfort. The study has been approved by an ethics committee.
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
- •Diagnosis of intrahepatic cholangiocarcinoma
- •Child-Pugh class A liver function
- •Planned neoadjuvant treatment with gemcitabine plus oxaliplatin, lenvatinib, and a PD-1 inhibitor
- •Planned anatomical hemihepatectomy with an expected future liver remnant greater than 40%
- •Age 18 to 75 years
- •Willing and able to participate and provide written informed consent
- •No acute illness or significant worsening of symptoms within 4 weeks before enrollment
排除标准
- •Serious coexisting medical conditions
- •Known allergy to phycocyanin
- •Other malignant tumors
- •Previous liver resection
- •History of severe psychiatric illness that may affect treatment adherence
研究组 & 干预措施
Phycocyanin Group
Participants will take 1.5 grams of phycocyanin by mouth once a day for 3 weeks before surgery and 3 weeks after surgery. They will also receive the usual medical care for partial liver removal surgery.
干预措施: Phycocyanin (Dietary Supplement)
Placebo Group
Participants will take 1.5 grams of maltodextrin placebo by mouth once a day for 3 weeks before surgery and 3 weeks after surgery. The placebo does not contain phycocyanin. Participants will also receive the usual medical care for partial liver removal surgery.
干预措施: Maltodextrin (Dietary Supplement)
结局指标
主要结局
Change in Serum Aspartate Aminotransferase (AST) Level
时间窗: Baseline and Week 3 after surgery
Change in Serum Alanine Aminotransferase (ALT) Level
时间窗: Baseline and Week 3 after surgery
Change in Serum Total Bilirubin (TBIL) Level
时间窗: Baseline and Week 3 after surgery
次要结局
- Change in Blood Inflammatory Marker Levels(Baseline and Week 3 after surgery)
- Liver Cell Proliferation Assessed by Ki-67 Expression(Baseline and Week 3 after surgery)
- Liver Cell Proliferation Assessed by PCNA Expression(Baseline and Week 3 after surgery)