Transfemoral Versus Transradial Approach in Transarterial Chemoembolization of Hepatocellular Carcinoma

Assiut University

Status: Not yet enrolling

Conditions: Hepatocellular Carcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT06543030

TACE

Details and patient eligibility

About

Transfemoral Versus Transradial Approach in Transarterial Chemoembolization of Hepatocellular Carcinoma

Full description

To compare transfemoral approach (TFA) and transradial approach (TRA) in patients undergoing hepatic chemoembolization in terms of safety, feasibility, and procedural variables, including fluoroscopy time and patient preference.

Enrollment: 60 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Hepatocellular carcinoma of BCLC (Barcelona Clinic Liver Cancer) stage B
• Also for BCLC stage A patients, in whom ablative therapy has technical limitations.
• Downsizing tumor for resection or transplantation.

Exclusion criteria

• Factors related to liver cirrhosis:

  • Decompensated cirrhosis (Child-Pugh B and C, score >8), including jaundice, clinical hepatic encephalopathy, and refractory ascites and/ or hepatorenal syndrome
  • Impaired portal-vein blood flow (portal-vein thrombus, hepatofugal blood flow)

• Factors related to HCC:

  • Extensive tumor involving the entirety of both lobes of the liver
  • Malignant portal vein thrombosis
  • Extra-hepatic metastases

• Impaired renal function:

  • Creatinine ≥2 mg/dl or creatinine clearance <30 ml/min

• Factors related to procedure (Radial artery access):

  • Existing AV (arteriovenous) fistula or graft
  • Pervious major surgery to forearm or wrist
  • Vasculitis
  • Pervious access failure
  • Skin infection or compromised integrity
  • Artery size <2mm
  • Intolerance of hyperextended wrist positioning
  • Severe vasospasm
  • Vessel tortuosity
  • Radial loops
  • Absent or occluded radial artery
  • Atherosclerotic or calcific PAD (peripheral artery disease)
  • Coagulopathy INR>1.5 platelets count <50.000/mmc

Trial design

60 participants in 2 patient groups

Transfemoral approach (TFA) group

Transradial approach (TRA) group