An interventional study of Spirulina and Maltodextrin in Cholangiocarcinoma, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-04.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment
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.
914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 687 interventional studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
participants take spirulina tablets (2 g/day) for 3 weeks before and 3 weeks after surgery.
Dietary Supplement: Spirulina
participants take placebo tablets (maltodextrin, same dosage and schedule).
Dietary Supplement: Maltodextrin
participants take spirulina tablets (2 g/day) for 3 weeks before and 3 weeks after surgery
Participants take placebo tablets (maltodextrin, same dosage and schedule).
Change in Alanine Aminotransferase (ALT) Level
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.
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
Serum AST will be measured at baseline and after the intervention. The analysis compares change from baseline between study arms.
Time frame: Day 0 (~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery)
Change in Total Bilirubin (TBIL) Level
Serum TBIL will be measured pre- and post-intervention. The change from baseline will be compared between groups.
Time frame: Day 0 (~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery)
Change in Serum Inflammatory Cytokine Concentrations
Serum inflammatory cytokines (e.g., IL-6, TNF-α) will be quantified using immunoassays before and after intervention. Analysis will compare changes from baseline.
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
Fecal metagenomic sequencing will assess gut microbial species abundance and alpha-diversity indices. The outcome is change in microbial composition from baseline to post-treatment.
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
Single-cell RNA sequencing and/or bulk RNA sequencing will be performed on liver tissue collected during partial hepatectomy to characterize cellular and molecular pathways related to liver injury and regeneration.
Time frame: During liver surgery (partial hepatectomy)
Number of Participants With Abnormal Hematology Laboratory Values
Complete blood count parameters will be assessed at baseline, during intervention, and at end of treatment. The outcome is the number of participants exhibiting abnormal values defined by institutional reference ranges.
Time frame: Day 0 (baseline) Perioperative period (during hospitalization) End of 6-week treatment (~3 weeks after surgery)
Number of Participants With Abnormal Renal Function Test Results
Renal function parameters including serum creatinine and blood urea nitrogen will be assessed. The number of participants with abnormal values will be reported.
Time frame: Day 0 Perioperative period End of 6-week treatment
Number of Participants With Abnormal Coagulation Function Test Results
Coagulation parameters including prothrombin time (PT), international normalized ratio (INR), and activated partial thromboplastin time (APTT) will be collected. Abnormal findings will be counted.
Time frame: Day 0 Perioperative period End of 6-week treatment
Number of Participants With Abnormal Urine Routine Test Results
Routine urinalysis including leukocytes, nitrites, protein, glucose, ketones, and microscopic examination will be performed. Abnormal results will be recorded.
Time frame: Day 0 Perioperative period End of 6-week treatment
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Second Affiliated Hospital, School of Medicine, Zhejiang University