Clinical trial · Interventional
Protective Mechanisms of Phycocyanin in Partial Hepatectomy-Associated Liver Injury
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intrahepatic Cholangiocarcinoma (Icc) | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.85 |
| Liver Injury | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Maltodextrin | Dietary Supplement | — | UNRESOLVED |
| Phycocyanin | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phycocyanin Group
- description
- Participants will take 1.5 grams of phycocyanin by mouth once a day for 3 weeks before surgery and 3 weeks after surgery. They will also receive the usual medical care for partial liver removal surgery.
- interventionNames
- Dietary Supplement: Phycocyanin
- type
- PLACEBO_COMPARATOR
- label
- Placebo Group
- description
- Participants will take 1.5 grams of maltodextrin placebo by mouth once a day for 3 weeks before surgery and 3 weeks after surgery. The placebo does not contain phycocyanin. Participants will also receive the usual medical care for partial liver removal surgery.
- interventionNames
- Dietary Supplement: Maltodextrin
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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% * Age 18 to 75 years * Willing and able to participate and provide written informed consent * No acute illness or significant worsening of symptoms within 4 weeks before enrollment Exclusion Criteria: * Serious coexisting medical conditions * Known allergy to phycocyanin * Other malignant tumors * Previous liver resection * History of severe psychiatric illness that may affect treatment adherence
References
Publications (0)
Data not yet available