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

Zhejiang University

Status: Enrolling

Conditions: Cholangiocarcinoma

Treatments: Dietary Supplement: Spirulina; Dietary Supplement: Maltodextrin

Study type: Interventional

Funder types: Other

Identifiers

NCT07263217

2025-0805

Details and patient eligibility

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups, including a placebo group

Spirulina treatment group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Spirulina

Placebo control group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Maltodextrin