Actively Recruiting
Mechanistic Study on the Protective and Regenerative Effects of Spirulina in Hepatectomy-Related Liver Injury
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-12-04
30
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Mechanistic Study on the Protective and Regenerative Effects of Spirulina in Hepatectomy-Related Liver Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 with remaining liver volume over 40%.
- Age between 18 and 75 years, male or female.
- Willing and able to follow the study protocol, including taking spirulina or placebo tablets for 3 weeks before and 3 weeks after surgery.
- Voluntarily agrees to participate and signs written informed consent.
- No acute illness or significant worsening of symptoms within 4 weeks before enrollment.
You will not qualify if you...
- Presence of severe uncontrolled cardiovascular, respiratory, renal, or hematologic diseases.
- Known allergy to spirulina or its components.
- Having other malignant tumors besides the target disease.
- History of previous liver resection surgery.
- Severe psychiatric disorders that affect compliance or ability to consent.
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Zhejiang University
Hangzhou, China
Actively Recruiting
Research Team
X
Xiaopeng Cai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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