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NCT Number: NCT06543030

Transfemoral Versus Transradial Approach in Transarterial Chemoembolization of Hepatocellular Carcinoma

Transfemoral Versus Transradial Approach in Transarterial Chemoembolization of Hepatocellular Carcinoma

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ali AA Sewisy, M.B.B.CH

CONTACT

[email protected]

+201142606214

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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