Spirulina to protect the liver and help recovery after partial hepatectomy

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

This trial will test whether taking spirulina tablets before and after surgery helps people with cholangiocarcinoma protect their liver and recover faster after a partial hepatectomy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (other)
• Drugs / interventions: lenvatinib
• Locations: 1 site (Hangzhou)
• Trial ID: NCT07263217 on ClinicalTrials.gov

What this trial studies

Participants are given either spirulina tablets or a placebo daily for three weeks before and three weeks after planned anatomical hemihepatectomy. The trial collects blood and stool samples, and a small piece of surgical liver tissue, to measure liver function, regeneration markers, and inflammation while monitoring for side effects. Regular clinic visits include blood tests and safety checks to track recovery and any adverse events. The design compares outcomes between the spirulina and placebo groups to determine whether spirulina provides protective or regenerative effects in the perioperative period.

Who should consider this trial

Good fit: Adults 18–75 with cholangiocarcinoma, Child-Pugh A liver function, planned neoadjuvant gemcitabine + oxaliplatin with lenvatinib and a PD-1 inhibitor, and scheduled anatomical hemihepatectomy with remaining liver volume >40% are ideal candidates.

Not a fit: Patients with poorer liver function (Child-Pugh B/C), prior liver resection, other active malignancies, severe uncontrolled comorbidities, or a known allergy to spirulina are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, spirulina could reduce liver injury, support regeneration, and lower post-operative complications to improve recovery after hepatectomy.

How similar studies have performed: Spirulina has shown hepatoprotective effects in preclinical models and limited clinical settings, but perioperative use around hepatectomy for cholangiocarcinoma is novel and not yet well established.

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.

Where this trial is running

Hangzhou

• The Second Affiliated Hospital of Zhejiang University — Hangzhou, China (RECRUITING)

Study contacts

• Study coordinator: Xiaopeng Cai

Conditions: Cholangiocarcinoma