Treatment of liver cancer using a bioartificial liver device after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, non-randomized, single-arm cohort study involving 10 patients who have undergone extensive hepatectomy for liver cancer. The study will apply a bioartificial liver device 48-72 hours post-surgery to assess its safety and effectiveness. Patients will be monitored in the ICU, with evaluations of liver function, liver volume, and the incidence of liver failure conducted at various intervals following treatment. The goal is to analyze recovery and regeneration of liver function after the intervention.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosed as liver cancer, hepatolithiasis, benign liver tumor, with clear indications for liver resection;
2. Liver function Child A-B;
3. There is no contraindication to surgery for cardiopulmonary function;
4. The expected remaining liver volume/standard liver volume is less than 50%;

Exclusion Criteria:

1. In the late stage of the disease, patients with frequent symptoms such as cerebral edema accompanied by cerebral herniation and clinical evidence indicating intracranial hemorrhage;
2. PaO2/FiO2 is less than 200 and cannot be corrected;
3. Patients with diffuse intravascular coagulation;
4. Those with active bleeding;
5. Uncontrolled infection;
6. The platelet count is less than 50,000/μL and cannot be corrected;
7. There is no blood vessel available for dialysis treatment;
8. HIV, HDV or HCV positive;
9. Drug abuse within 1 year;
10. Those with severe systemic circulatory failure;
11. Those who are highly allergic to the drugs used in the treatment process, such as plasma, heparin, protamine, etc.;
12. Combined pregnancy;
13. Patients with hepatorenal syndrome;
14. Patients with autoimmune liver disease;
15. Patients with non-alcoholic fatty liver and hereditary liver diseases (Wilson syndrome and a-antitrypsin deficiency);
16. Other conditions that the clinician believes cannot tolerate the treatment.

Where it's running

• Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Yifan Wang, MD — Sir Run Run Shaw Hospital
• Study coordinator: Xiujun Cai, MD
• Email: caixiujunzju@yahoo.com.cn
• Phone: 0086-0571-86006605

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• MDN-001 (Yttrium-90 microsphere) injection for unresectable liver cancer

  This will test MDN-001 (a Yttrium-90 microsphere injection) as a treatment for adults with unresectable hepatocellular carcinoma to see if it controls tumors and is safe.

  Recruiting at 8 sites Phase 1 Suzhou Mednovo Yi Medical Technology Co., Ltd. · Hefei, Anhui and 7 other locations · NCT07391839

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.