Transfemoral Versus Transradial Approach in Transarterial Chemoembolization of Hepatocellular Carcinoma

NCT06543030 | Not Yet Recruiting

• 1 other identifier: TACE
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Transfemoral Versus Transradial Approach in Transarterial Chemoembolization of Hepatocellular Carcinoma

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• To compare transfemoral approach (TFA) and transradial approach (TRA) in patients undergoing hepatic chemoembolization

  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.

  Baseline

Study Arms (2)

Transfemoral approach (TFA) group

Transradial approach (TRA) group

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinics of Assuit university hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University hospitals

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Ali AA Sewisy, M.B.B.CH

CONTACT

+201142606214; aliadelsewisy@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.B.B.CH at Radiology department of Assuit university

Study Record Dates

• First Submitted: August 3, 2024
• First Posted: August 7, 2024
• Study Start: August 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

EG (1)