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

NCT ID: NCT07263217

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2028-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Spirulina treatment group

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

Group Type: EXPERIMENTAL

Spirulina

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo control group

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

Group Type: PLACEBO_COMPARATOR

Maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Spirulina

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

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin

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

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital of Zhejiang University

Hangzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaopeng Cai

Role: CONTACT

cxpeng@zju.edu.cn

+86 18768161626

Facility Contacts

Xiaopeng Cai

Role: primary

cxpeng@zju.edu.cn

+86 18768161626

Other Identifiers

2025-0805

Identifier Type: -

Identifier Source: org_study_id