Hepatocellular CarcinomaNCT06543030
Transfemoral Versus Transradial Approach in Transarterial Chemoembolization of Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by Assiut University at 1 site in Egypt.
Trial summary
Transfemoral Versus Transradial Approach in Transarterial Chemoembolization of Hepatocellular Carcinoma Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2024to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Primary care clinics of Assuit university hospital.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 23Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Transfemoral Versus Transradial Approach in Transarterial Chemoembolization of Hepatocellular Carcinoma
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transfemoral approach (TFA) group | Not described | |
| Transradial approach (TRA) group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study startAug 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Adel Abouelmagd Sewisy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543030
- Sponsor's protocol ID
- TACE
- Status last verified
- Aug 2024
- First submitted
- 3 Aug 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfemoral Versus Transradial Approach in Transarterial Chemoembolization of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06543030
- Acronym / sponsor ID
- TACE
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transfemoral approach (TFA) group | – | – |
| Transradial approach (TRA) group | – | – |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care clinics of Assuit university hospital.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (23 listed)
- Factors related to liver cirrhosis:
- Factors related to HCC:
- Impaired renal function:
- Factors related to procedure (Radial artery access):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali AA Sewisy, M.B.B.CH (+201142606214, aliadelsewisy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare transfemoral approach (TFA) and transradial approach (TRA) in patients undergoing hepatic chemoembolization (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.