Transfemoral Versus Transradial Approach in Transarterial Chemoembolization of Hepatocellular Carcinoma

NCT ID: NCT06543030

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-31

Study Completion Date

2025-12-31

Brief Summary

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Transfemoral Versus Transradial Approach in Transarterial Chemoembolization of Hepatocellular Carcinoma

Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Transfemoral approach (TFA) group

No interventions assigned to this group

Transradial approach (TRA) group

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ali Adel Abouelmagd Sewisy

M.B.B.CH at Radiology department of Assuit university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University hospitals

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Ali AA Sewisy, M.B.B.CH

Role: CONTACT

+201142606214

Other Identifiers

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TACE

Identifier Type: -

Identifier Source: org_study_id

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