Transfemoral Versus Transradial Approach in Transarterial Chemoembolization of Hepatocellular Carcinoma

Not yet recruiting

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT06543030
• Lead Sponsor: Assiut University

Brief Summary

Transfemoral Versus Transradial Approach in Transarterial Chemoembolization of Hepatocellular Carcinoma

Detailed 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.

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08
• Study First Submitted: 2024-08-03
• Study First Submitted QC: 2024-08-03
• Last Update Submitted: 2024-08-03
• Study First Posted: 2024-08-07
• Last Update Posted: 2024-08-07
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare transfemoral approach (TFA) and transradial approach (TRA) in patients undergoing hepatic chemoembolization	Baseline	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.

Trial Locations

Locations (1)

Assiut University hospitals; 🇪🇬 Assiut, Egypt