Hepatocellular CarcinomaNRUNCT03129685
Ipsilateral Liver Lobe Devascularization of the Large Hepatocellular Carcinoma
A study testing HALED in people with Hepatocellular Carcinoma, run by The National Ribat University at 1 site in Sudan.
Trial summary
Assessment of short-term outcomes of ipsilateral lobe arterial devascularization of the large 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
- What is being tested?
- HALED
- Type of treatment
- 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 19 Dec 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;
- 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: Short-term Outcome of Ipsilateral Liver Lobe Devascularization of the Large Hepatocellular Carcinoma
Assessment of short-term outcomes of ipsilateral lobe arterial devascularization of the large hepatocellular carcinoma: single center non-randomized trial.
Read the detailed description
Assessment of the 30-day mortality and major complications as well as the tumor size changes of the patients undergoing ipsilateral lobe arterial devascularization of the large hepatocellular carcinoma. This is a prospective non randomized trial carried out at the Ribat University Hospital between April 2017 to March 2018.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- HALED
- Keywords
- Hepatocellular carcinoma, Devascularization
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HALEDProcedure or surgery
This is attained via a laparotomy involves isolation of the arterial blood supply of the tumor-containing liver lobe (the ipsilateral hepatic artery as well as the extrahepatic arterial collaterals) while preserving the feeding veins.
| Study group | Role | What they receive |
|---|---|---|
| Devascularization | Experimental | Patients undergoing ipsilateral hepatic artery ligation with extrahepatic collaterals division (HALED) Receives: Procedure: HALED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short term mortality rate
Percentage of patients' postoperative deaths
Measured: 30 day
Secondary outcomes (2)
Short term major complications' rate
Incidence of Clavien/Dindo grade 3 or more postoperative complications
Measured: 30 days
Tumor response rate according to mRECIST criteria.
Estimation of the residual percentage of viable tumor following the devascularization.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start20 May 2017
- Primary completion19 Nov 2018 (estimated)
- Study completion19 Dec 2018 (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 and non-randomized 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, Faculty of Medicine. The National Ribat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129685
- Sponsor's protocol ID
- IS-001-17
- Acronym
- NRU
- Status last verified
- Jun 2018
- First submitted
- 23 Apr 2017
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Elsanousi OM, Mohamed MA, Salim FH, Adam EA. Selective devascularization treatment for large hepatocellular carcinoma: Stage 2A IDEAL prospective case series. Int J Surg. 2019 Aug;68:134-141. doi: 10.1016/j.ijsu.2019.06.014. Epub 2019 Jun 29.
PubMed 31265917
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Outcome of Ipsilateral Liver Lobe Devascularization of the Large Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03129685
- Acronym / sponsor ID
- NRU / IS-001-17
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, Devascularization
- 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
- 19 Nov 2018 (estimated)
- Study completion
- 19 Dec 2018 (estimated)
- First posted
- 26 Apr 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 short-term outcomes of ipsilateral lobe arterial devascularization of the large hepatocellular carcinoma: single center non-randomized trial.
Detailed description
Assessment of the 30-day mortality and major complications as well as the tumor size changes of the patients undergoing ipsilateral lobe arterial devascularization of the large hepatocellular carcinoma. This is a prospective non randomized trial carried out at the Ribat University Hospital between April 2017 to March 2018.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective and non-randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Devascularization | Experimental | Procedure: HALEDPatients undergoing ipsilateral hepatic artery ligation with extrahepatic collaterals division (HALED) |
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 (8 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 |
|---|---|---|
| HALEDThis is attained via a laparotomy involves isolation of the arterial blood supply of the tumor-containing liver lobe (the ipsilateral hepatic artery as well as the extrahepatic arterial collaterals) while preserving the feeding veins. | Procedure or surgery | Devascularization |
Primary outcome
Short term mortality rate
Time frame: 30 day
Percentage of patients' postoperative deaths
2 secondary outcomes
Short term major complications' rate
Time frame: 30 days
Tumor response rate according to mRECIST criteria.
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
- Derived from this study: PubMed 31265917Elsanousi OM, Mohamed MA, Salim FH, Adam EA. Selective devascularization treatment for large hepatocellular carcinoma: Stage 2A IDEAL prospective case series. Int J Surg. 2019 Aug;68:134-141. doi: 10.1016/j.ijsu.2019.06.014. Epub 2019 Jun 29.
- Individual participant dataSharing planned: Yes
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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
Faculty of Medicine. 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 HALED 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 8 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 12 Jun 2018. 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?
Short term mortality rate (time frame: 30 day). 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 NCT03129685, 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 12 Jun 2018.