Liver metastases Liver metastases
Conditions
Interventions
Fragmented gelatin particles are injected under balloon occlusion through a catheter inserted into the hepatic artery.
D002406
embolizatiion
Sponsors
Hoshiai Sodai
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with liver metastases that are high-density or high-signal compared to liver parenchyma in the arterial phase of contrast-enhanced CT or contrast-enhanced MRI 2) Refractory or intolerant to the standard treatment indicated in the guidelines for the primary tumor 3) Patients with or without extrahepatic lesions. 4) Male or female, 18 years of age or older. 5) ECOG Performance Status is 0 to 1. 6) Patient's own consent has been obtained.
Exclusion criteria
Exclusion criteria: 1) Serum bilirubin level is greater than 2.0 mg/dl 2) Renal function eGFR is less than 40ml/min 3) Platelet count is less than 50,000/mm3 4) PT INR greater than 1.5 5) Tumor thrombi are present in the main trunk or first branch of the portal vein, or hepatic vein 6) Tumor volume in excess of 70% of liver 7) Bile duct dilatation 8) Severe arterial-portal shunt or arterial-venous shunt 9) Severe mental retardation 10) Allergy to iodine contrast media or severe allergy to other drugs 11) Patients who are judged by the principal investigator to be unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of Transarterial Embolization with Fragmented Gelatin Particles under Balloon Occlusion for Hypervascular Liver Metastases Refractory or Intolerant to Standard Treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Treatment effect of liver metastases after 8 weeks based on mRECIST 2) Change in Child-Pugh score | — |
Contacts
Public ContactSodai Hoshiai
University of Tsukuba Hospital
Outcome results
None listed