Hepatocellular Carcinoma Non-resectableNCT03138031
Percutaneous Ethanol Alcohol Injection for the Large and Unresectable Hepatocellular Carcinoma
A study testing Percutaneous ethanol alcohol injection in people with Hepatocellular Carcinoma Non-resectable, run by The National Ribat University at 1 site in Sudan.
Trial summary
Assessment of the long-term outcome of percutaneous ethanol alcohol injection (PEI) for the large and unresectable hepatocellular carcinoma: single center non-randomized trial. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma Non-resectable
- What is being tested?
- Percutaneous ethanol alcohol injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSudan
- Study dates
- 1 May 2017to 30 May 2018
- 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 80 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;
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- Severe thrombocytopenia;
- Unable or unwilling to attend follow up visits and examinations;
- Other associated surgical procedure;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome of Percutaneous Ethanol Alcohol Injection (PEI) for the Large and Unresectable Hepatocellular Carcinoma.
Assessment of the long-term outcome of percutaneous ethanol alcohol injection (PEI) for the large and unresectable hepatocellular carcinoma: 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 (PAT or PEI) for the large and inoperable hepatocellular carcinoma. This is a prospective non randomized trial carried out at the Ribat University Hospital between May 2017 to April 2020.
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Being tested
- Percutaneous ethanol alcohol injection
- Keywords
- Percutaneuos Ethanol alcohol injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous ethanol alcohol injectionProcedure or surgery
Day-case procedure; weekly sessions; uses absolute alcohol; under close monitoring; maximum dose of 30 ml; no anesthesia needed and a maximum pain score of "8" limits the procedure. Post-procedure analgesia may be required.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Ethanol Injection (PEI) | Experimental | Those participants receive percutaneous ethanol alcohol injection for the large and unresectable HCC. Absolute alcohol; weekly sessions; under close monitoring; maximum of 30 mls; no anaesthesia needed and a maximum pain score of "8" during the procedure. Postprocedure analgesia may be required. Receives: Procedure: Percutaneous ethanol alcohol injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate
The percentage of HCC patients who are still alive for three years after they started PEI for HCC.
Measured: 3 years
Secondary outcomes (3)
Disease free survival
Percentage of HCC patients who are alive and well (without a recurrence of their HCC) 3 years after PEI.
Measured: 3 years
Major complications' rate
Incidence of post-procedure 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 start1 May 2017
- Primary completion1 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma Non-resectableStudies 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
- Single Group Assignment. Prospective and non-randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
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 UniversityMurtada M Mohamed, MD, Principal investigator, Ribat University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138031
- Sponsor's protocol ID
- IS-002-17
- Status last verified
- Sep 2017
- 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
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
- Outcome of Percutaneous Ethanol Alcohol Injection (PEI) for the Large and Unresectable Hepatocellular Carcinoma.
- ClinicalTrials.gov ID
- NCT03138031
- Acronym / sponsor ID
- IS-002-17
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Keywords
- Percutaneuos Ethanol alcohol injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- The National Ribat UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- 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 percutaneous ethanol alcohol injection (PEI) for the large and unresectable hepatocellular carcinoma: 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 (PAT or PEI) for the large and inoperable hepatocellular carcinoma. 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
- Single Group Assignment. Prospective and non-randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Ethanol Injection (PEI) | Experimental | Procedure: Percutaneous ethanol alcohol injectionThose participants receive percutaneous ethanol alcohol injection for the large and unresectable HCC. Absolute alcohol; weekly sessions; under close monitoring; maximum of 30 mls; no anaesthesia needed and a maximum pain score of "8" during the procedure. Postprocedure analgesia may be required. |
Who may qualify
- Ages
- 15 to 80 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 (9 listed)
- American Anesthesia Association (ASA) Class IV or V and/or any
- contraindications to general anesthesia;
- Uncontrollable ascites;
- Deep persistent jaundice;
- Hepatic encephalopathy;
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 |
|---|---|---|
| Percutaneous ethanol alcohol injectionDay-case procedure; weekly sessions; uses absolute alcohol; under close monitoring; maximum dose of 30 ml; no anesthesia needed and a maximum pain score of "8" limits the procedure. Post-procedure analgesia may be required. | Procedure or surgery | Percutaneous Ethanol Injection (PEI) |
Primary outcome
Overall survival rate
Time frame: 3 years
The percentage of HCC patients who are still alive for three years after they started PEI for HCC.
3 secondary outcomes
Disease free survival
Time frame: 3 years
Major complications' rate
Time frame: 3 years
Tumor response rate
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- 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
Murtada M Mohamed, MD principal investigator
Ribat University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous ethanol alcohol injection in people with Hepatocellular Carcinoma Non-resectable, 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 9 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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?
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.