Safety Study of Transarterial Embolization under Balloon Occlusion with Fragmented Gelatin Particles for Hypervascular Liver Metastases Refractory or Intolerant to Standard Treatment
- Conditions
- iver metastasesLiver metastasesD009362
- Registration Number
- JPRN-jRCTs032220172
- Lead Sponsor
- Hoshiai Sodai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method