Hepatocellular CarcinomaNCT03138044
Combined Ipsilateral Liver Lobe Devascularization and Alcohol Treatment of the Large Hepatocellular Carcinoma
A study testing Combined Treatment in people with Hepatocellular Carcinoma, run by The National Ribat University at 1 site in Sudan.
Trial summary
Assessment of the long-term outcome of combined ipsilateral liver lobe devascularization (ILAD) and alcohol injection of the large hepatocellular carcinoma (HCC): single center non-randomized trial. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Combined Treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSudan
- Study dates
- 20 May 2017to 30 Apr 2020
- Phase
- Interventional
- 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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Review and sign informed consent;
- Between 15 and 80 years of age at time of trial enrollment;
- Documented pathological and/or radiological diagnosis of hepatocellular carcinoma;
- Radiologically documented tumor size of > 5 centimeters;
- Radiologically documented liver cirrhosis.
Who cannot join
- American Anesthesia Association (ASA) Class IV or V and/or any contraindications to general anesthesia;
- Uncontrollable ascites;
- Deep persistent jaundice;
- Hepatic encephalopathy;
- Coagulopathy;
- Severe uncorrectable thrombocytopenia;
- Unable or unwilling to attend follow up visits and examinations;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Outcome of Combined Ipsilateral Liver Lobe Devascularization and Alcohol Treatment (CILDAT) of the Large Hepatocellular Carcinoma (HCC)
Assessment of the long-term outcome of combined ipsilateral liver lobe devascularization (ILAD) and alcohol injection of the large hepatocellular carcinoma (HCC): single center non-randomized trial.
Read the detailed description
Assessment of the overall (OS); one year; two years and three years' survival rates; the disease free survival (DFS) and the tumor response rate in the patients undergoing Combined Ipsilateral Liver Lobe Devascularization and Alcohol Treatment (CILDAT) of the Large HCC. This is a prospective non randomized trial carried out at the Ribat University Hospital between May 2017 to April 2020.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Combined Treatment
- Keywords
- Hepatocellular Carcinoma, Ipsilateral Liver Lobe Devascularization, Alcohol Treatment, CILDAT
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined TreatmentProcedure or surgery
Also called CILDAT
This modality of palliative treatment includes initial surgical operation where arterial vascular supply of the tumor carrying liver lobe of the corresponding hepatic artery as well as the extrahepatic collateral arteries (EHCAs) feeding the large HCC (> 5 cms size) under general anesthesia. Four weeks after the operation the tumor is injeted (intralesionally and intravascularly) with absolute ethanol alcohol injections on regular weekly percutaneous sessions until the tumor become saturated and its vascularity rendered inactive.
| Study group | Role | What they receive |
|---|---|---|
| Combined Treatment | Experimental | The Combined Treatment: patients undergo a surgical operation of ipsilateral liver lobe devascularization and four weeks later after the operation percutaneous alcohol injection sessions. Receives: Procedure: Combined Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate
The percentage of patients who are still alive for three years after they started CILDAT for their large HCC.
Measured: 3 years
Secondary outcomes (4)
Disease free survival
Percentage of HCC patients who are alive and well (without a recurrence of their HCC) 3 years after CILDAT
Measured: 3 years
Major complications' rate
Incidence of post CILDAT Clavien-Dindo comlicatins grade 3b or more.
Measured: 3 years
Major toxicity rate
Incidence of post CILDAT Common Terminology Criteria for Adverse Events (CTCAE v4.03) grade
Measured: 3 years
Tumor response rate
Mean percentage reduction in the sizes of the patients' tumors
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start20 May 2017
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non-randomized and time series clinical trial.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The National Ribat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Mohamed Elsanousi, The National Ribat University
- Investigators
- Osama M Elsanousi, MD, Principal investigator, The National Ribat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138044
- Sponsor's protocol ID
- IS-003-17
- Status last verified
- May 2019
- First submitted
- 30 Apr 2017
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elsanousi OM, Mohamed MA, Salim FH, Adam EA, Bedri S. Long-term outcome of novel combined surgical-injection treatment (COSIT) for large hepatocellular carcinoma: Stage 2A IDEAL prospective case series. Ann Med Surg (Lond). 2021 Nov 24;72:103098. doi: 10.1016/j.amsu.2021.103098. eCollection 2021 Dec.
PubMed 34888043
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Outcome of Combined Ipsilateral Liver Lobe Devascularization and Alcohol Treatment (CILDAT) of the Large Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT03138044
- Acronym / sponsor ID
- IS-003-17
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Ipsilateral Liver Lobe Devascularization, Alcohol Treatment, CILDAT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- The National Ribat UniversityUniversity, hospital or other
- Study start
- 20 May 2017 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 3 May 2017 (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.
Assessment of the long-term outcome of combined ipsilateral liver lobe devascularization (ILAD) and alcohol injection of the large hepatocellular carcinoma (HCC): single center non-randomized trial.
Detailed description
Assessment of the overall (OS); one year; two years and three years' survival rates; the disease free survival (DFS) and the tumor response rate in the patients undergoing Combined Ipsilateral Liver Lobe Devascularization and Alcohol Treatment (CILDAT) of the Large HCC. This is a prospective non randomized trial carried out at the Ribat University Hospital between May 2017 to April 2020.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-randomized and time series clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Combined Treatment | Experimental | Procedure: Combined TreatmentThe Combined Treatment: patients undergo a surgical operation of ipsilateral liver lobe devascularization and four weeks later after the operation percutaneous alcohol injection sessions. |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Review and sign informed consent;
- Between 15 and 80 years of age at time of trial enrollment;
- Documented pathological and/or radiological diagnosis of hepatocellular carcinoma;
- Radiologically documented tumor size of > 5 centimeters;
- Radiologically documented liver cirrhosis.
Key exclusion criteria (7 listed)
- American Anesthesia Association (ASA) Class IV or V and/or any contraindications to general anesthesia;
- Uncontrollable ascites;
- Deep persistent jaundice;
- Hepatic encephalopathy;
- Coagulopathy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined TreatmentAlso: CILDATThis modality of palliative treatment includes initial surgical operation where arterial vascular supply of the tumor carrying liver lobe of the corresponding hepatic artery as well as the extrahepatic collateral arteries (EHCAs) feeding the large HCC (> 5 cms size) under general anesthesia. Four weeks after the operation the tumor is injeted (intralesionally and intravascularly) with absolute ethanol alcohol injections on regular weekly percutaneous sessions until the tumor become saturated and its vascularity rendered inactive. | Procedure or surgery | Combined Treatment |
Primary outcome
Overall survival rate
Time frame: 3 years
The percentage of patients who are still alive for three years after they started CILDAT for their large HCC.
4 secondary outcomes
Disease free survival
Time frame: 3 years
Major complications' rate
Time frame: 3 years
Major toxicity rate
Time frame: 3 years
Tumor response rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Derived from this study: PubMed 34888043Elsanousi OM, Mohamed MA, Salim FH, Adam EA, Bedri S. Long-term outcome of novel combined surgical-injection treatment (COSIT) for large hepatocellular carcinoma: Stage 2A IDEAL prospective case series. Ann Med Surg (Lond). 2021 Nov 24;72:103098. doi: 10.1016/j.amsu.2021.103098. eCollection 2021 Dec.
- Individual participant dataSharing planned: No
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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.
Osama M Elsanousi, MD principal investigator
The National Ribat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Treatment in people with Hepatocellular Carcinoma, run by The National Ribat University at 1 site in Sudan.
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 5 inclusion and 7 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 14 May 2019. 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 Sudan. 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 Osama M Elsanousi, MD (+249 1222 29574, osamagreen55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival rate (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03138044, which also lists 1 linked publication.
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 14 May 2019.