Safety Study of Transarterial Embolization under Balloon Occlusion with Fragmented Gelatin Particles for Hypervascular Liver Metastases Refractory or Intolerant to Standard Treatment

JRCT ID: jRCTs032220172

Registered date:30/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Liver metastases
• Date of first enrollment: 30/08/2022
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Fragmented gelatin particles are injected under balloon occlusion through a catheter inserted into the hepatic artery.

Outcome(s)

• Primary Outcome: Safety of Transarterial Embolization with Fragmented Gelatin Particles under Balloon Occlusion for Hypervascular Liver Metastases Refractory or Intolerant to Standard Treatment

Secondary Outcome

1) Treatment effect of liver metastases after 8 weeks based on mRECIST
2) Change in Child-Pugh score

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Hoshiai Sodai
• Source(s) of Monetary Support: University of Tsukuba Hospital