Mechanistic Study on the Protective and Regenerative Effects of Spirulina in Hepatectomy-Related Liver Injury

NCT07263217 | Recruiting

• 1 other identifier: 2025-0805
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cholangiocarcinoma

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (3)

• Change in Serum Inflammatory Cytokine Concentrations

  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

  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

  During liver surgery (partial hepatectomy)

Other Outcomes (4)

• Number of Participants With Abnormal Hematology Laboratory Values

  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

  Day 0 Perioperative period End of 6-week treatment

• Number of Participants With Abnormal Coagulation Function Test Results

  Day 0 Perioperative period End of 6-week treatment

Study Arms (2)

Spirulina treatment group

EXPERIMENTAL

participants take spirulina tablets (2 g/day) for 3 weeks before and 3 weeks after surgery.

Dietary Supplement: Spirulina

Placebo control group

PLACEBO COMPARATOR

participants take placebo tablets (maltodextrin, same dosage and schedule).

Dietary Supplement: Maltodextrin

Interventions

Spirulina DIETARY_SUPPLEMENT

participants take spirulina tablets (2 g/day) for 3 weeks before and 3 weeks after surgery

Spirulina treatment group

Maltodextrin DIETARY_SUPPLEMENT

Participants take placebo tablets (maltodextrin, same dosage and schedule).

Placebo control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University

Hangzhou, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Xiaopeng Cai

CONTACT

+86 18768161626; cxpeng@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 4, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-10

Locations

CN (1)