The goal of this study is to find out whether phycocyanin, a natural protein from spirulina, can help protect the liver and support recovery in adults having part of their liver removed. The study will also look at whether phycocyanin is safe to take.The main questions are:
Does phycocyanin reduce liver injury after surgery? Does it help the liver grow back and recover? What side effects or medical problems happen while taking it?
Researchers will compare phycocyanin with a placebo, which looks similar but does not contain phycocyanin. About 30 people will take part. Each person will be randomly placed into one of the two groups, and neither the participants nor the researchers will know which treatment each person receives during the study.
Participants will:
Take 1.5 grams of phycocyanin or placebo every day for 3 weeks before surgery and 3 weeks after surgery Receive the usual care for liver surgery Give blood and stool samples before and after treatment Allow researchers to study a small piece of liver tissue removed during surgery Return for follow-up for up to 90 days after surgery
The samples will be used to check liver function, inflammation, gut bacteria, and changes linked to liver healing. Possible side effects include an allergic reaction or stomach discomfort. The study has been approved by an ethics committee.
Diagnosis of intrahepatic cholangiocarcinoma
Child-Pugh class A liver function
Planned neoadjuvant treatment with gemcitabine plus oxaliplatin, lenvatinib, and a PD-1 inhibitor
Planned anatomical hemihepatectomy with an expected future liver remnant greater than 40%
Serious coexisting medical conditions
Known allergy to phycocyanin
Other malignant tumors
Previous liver resection
Parallel
Phycocyanin
Dietary supplementParticipants will take 1.5 grams of phycocyanin by mouth once daily for 3 weeks before partial hepatectomy and for 3 weeks after surgery. Phycocyanin is a natural protein from spirulina.
Maltodextrin
Dietary supplementParticipants will take 1.5 grams of maltodextrin placebo by mouth once daily for 3 weeks before partial hepatectomy and for 3 weeks after surgery. The placebo does not contain phycocyanin.
Change in Serum Aspartate Aminotransferase (AST) Level
Change in Serum Alanine Aminotransferase (ALT) Level
Change in Serum Total Bilirubin (TBIL) Level
Change in Blood Inflammatory Marker Levels
Liver Cell Proliferation Assessed by Ki-67 Expression
Liver Cell Proliferation Assessed by PCNA Expression
Incidence of Treatment-Emergent Adverse Events
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