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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spirulina treatment group | Experimental | participants take spirulina tablets (2 g/day) for 3 weeks before and 3 weeks after surgery. |
|
| Placebo control group | Placebo Comparator | participants take placebo tablets (maltodextrin, same dosage and schedule). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spirulina | Dietary Supplement | participants take spirulina tablets (2 g/day) for 3 weeks before and 3 weeks after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Day 0 (~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 (baseline) Perioperative period (during hospitalization) End of 6-week treatment (~3 weeks after surgery) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaopeng Cai | Contact | +86 18768161626 | cxpeng@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University | Recruiting | Hangzhou | China |
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| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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| Maltodextrin | Dietary Supplement | Participants take placebo tablets (maltodextrin, same dosage and schedule). |
|
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. |
| 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. | During liver surgery (partial hepatectomy) |
| 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. | 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. | 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. | Day 0 Perioperative period End of 6-week treatment |
| D009369 | Neoplasms |