Spirulina for Liver Protection and Regeneration in Hepatectomy Patients
The study aims to evaluate if taking spirulina helps protect and regenerate the liver in patients who have undergone liver surgery, by measuring changes in specific liver enzyme levels.
Spirulina
+ Maltodextrin
Adenocarcinoma+3
+ Carcinoma
+ Neoplasms
Treatment Study
Summary
Study start date: October 1, 2025
Actual date on which the first participant was enrolled.This clinical trial aims to investigate whether spirulina, a type of algae often used as a dietary supplement, can help protect the liver and aid in its recovery following a partial hepatectomy, which is a surgery to remove part of the liver. The study focuses on patients undergoing this surgery to see if spirulina can improve liver function, promote regeneration, and reduce inflammation. Understanding the safety of spirulina in this context is also a key component. The findings from this study could lead to new ways to support liver recovery in patients with liver diseases or those undergoing liver surgery, potentially improving outcomes and reducing complications. Participants in the study will be asked to take tablets containing either spirulina or a placebo for three weeks before and three weeks after their surgery. They will also provide blood and stool samples at various points to help researchers assess changes in liver function. Additionally, a small piece of liver tissue, collected during surgery, will be analyzed to provide further insights. Regular clinic visits will ensure participants' safety and allow for continuous monitoring of their health. The study evaluates liver function by measuring changes in specific liver enzymes and bilirubin levels, comparing results between the spirulina and placebo groups. This approach helps determine if spirulina has a beneficial effect on liver health during the recovery process.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
The Second Affiliated Hospital of Zhejiang University
Hangzhou, ChinaOpen The Second Affiliated Hospital of Zhejiang University in Google Maps