Protective Mechanisms of Phycocyanin in Partial Hepatectomy-Associated Liver Injury
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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Xiaopeng Cai
- 电话号码:+86 18768161626
- 邮箱:cxpeng@zju.edu.cn
学习地点
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Zhejiang
-
Hangzhou、Zhejiang、中国
- 招聘中
- The Second Affiliated Hospital of Zhejiang University
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接触:
- Xiaopeng Cai
- 电话号码:+86 18768161626
- 邮箱:cxpeng@zju.edu.cn
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Serious coexisting medical conditions
- Known allergy to phycocyanin
- Other malignant tumors
- Previous liver resection
- History of severe psychiatric illness that may affect treatment adherence
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的: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.
|
Participants will take 1.5 grams of phycocyanin by mouth once daily for 3 weeks before partial hepatectomy and for 3 weeks after surgery.
Phycocyanin is a natural protein from spirulina.
|
|
安慰剂比较: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.
|
Participants will take 1.5 grams of maltodextrin placebo by mouth once daily for 3 weeks before partial hepatectomy and for 3 weeks after surgery.
The placebo does not contain phycocyanin.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change in Serum Aspartate Aminotransferase (AST) Level
大体时间:Baseline and Week 3 after surgery
|
Baseline and Week 3 after surgery
|
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Change in Serum Alanine Aminotransferase (ALT) Level
大体时间:Baseline and Week 3 after surgery
|
Baseline and Week 3 after surgery
|
|
Change in Serum Total Bilirubin (TBIL) Level
大体时间:Baseline and Week 3 after surgery
|
Baseline and Week 3 after surgery
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Change in Blood Inflammatory Marker Levels
大体时间:Baseline and Week 3 after surgery
|
Baseline and Week 3 after surgery
|
|
Liver Cell Proliferation Assessed by Ki-67 Expression
大体时间:Baseline and Week 3 after surgery
|
Baseline and Week 3 after surgery
|
|
Liver Cell Proliferation Assessed by PCNA Expression
大体时间:Baseline and Week 3 after surgery
|
Baseline and Week 3 after surgery
|
其他结果措施
结果测量 |
大体时间 |
|---|---|
|
Incidence of Treatment-Emergent Adverse Events
大体时间:through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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