Mechanistic Study on the Protective and Regenerative Effects of Spirulina in Hepatectomy-Related Liver Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spirulina, Maltodextrin.
- Who it may be relevant to
- Registry conditions: Cholangiocarcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Dietary supplement Spirulina
participants take spirulina tablets (2 g/day) for 3 weeks before and 3 weeks after surgery - Dietary supplement Maltodextrin
Participants take placebo tablets (maltodextrin, same dosage and schedule).
Primary outcome measures
- Change in Alanine Aminotransferase (ALT) Level [Time frame: Day 0 (pre-treatment, ~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery)]
- Change in Aspartate Aminotransferase (AST) Level [Time frame: Day 0 (~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery)]
- Change in Total Bilirubin (TBIL) Level [Time frame: Day 0 (~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery)]
Secondary outcome measures (3)
- Change in Serum Inflammatory Cytokine Concentrations [Time frame: 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 [Time frame: 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 [Time frame: During liver surgery (partial hepatectomy)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Second Affiliated Hospital of Zhejiang University — Hangzhou
Identifiers
NCT: NCT07263217 · 2025-0805