RecruitingNot ApplicableNCT07263217

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


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

30 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether spirulina — a blue-green algae with antioxidant and anti-inflammatory properties — taken before and after major liver surgery (hemihepatectomy) can protect the liver and help it recover faster in patients with bile duct cancer. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with cholangiocarcinoma (bile duct cancer) - You are scheduled for hemihepatectomy (removal of part of the liver) - You are receiving standard combination drug therapy before surgery - You have good liver function (Child-Pugh Class A) and remaining liver will be at least 40% after surgery **You may NOT be eligible if...** - Your liver function is poor (Child-Pugh B or C) - Your planned remaining liver is less than 40% - You have had a recent acute illness affecting the study - You are unwilling to take spirulina or placebo for the study period Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTSpirulina

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

DIETARY_SUPPLEMENTMaltodextrin

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


Locations(1)

The Second Affiliated Hospital of Zhejiang University

Hangzhou, China

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NCT07263217


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