Hepatocellular Carcinoma (HCC)NCT02990351
Efficacy of Loco-regional Treatment for Hepatocellular Carcinoma Prior to Living Donor Liver Transplantation in Egypt
An observational study of Hepatocellular Carcinoma (HCC) and Living Donor Liver Transplantation, run by Ain Shams University.
Trial summary
This study aimed to analyze the outcomes of loco-regional treatment prior Living Donor Liver Transplantation in patients with HCC. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Living Donor Liver Transplantation
- What is being tested?
- loco regional therapies for HCC
- Type of treatment
- Surgery or procedure
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Dec 2015
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Egyptian patients prepared for living donor liver transplantation , at Ain Shams Centre for Organ Transplantation (ASCOT) , Cairo Egypt
Who may be able to join
- Adult patients 18-65 years
- Patients transplanted for HCC within Milan and UCSF criteria who underwent pre transplant bridge or down staging treatment for HCC
Who cannot join
- Tumor progression on the waiting list
- Vascular invasion by imaging studies
- Extrahepatic or lymph node metastasis
About this study
Official title: Loco-regional Treatment for HCC Patients
This study aimed to analyze the outcomes of loco-regional treatment prior Living Donor Liver Transplantation in patients with HCC.
Read the detailed description
50 patients received LDLT at Ain Shams Centre for Organ Transplantation (ASCOT) over 1 year of whom data of 29 HCC patients were analyzed. Twenty patients met the Milan criteria (68.97%) \& 4 (13.8%) were beyond Milan but met UCSF criteria and 5 were exceeding UCSF criteria (17.2%).All patients underwent preoperative LRTs, The protocol of bridging/down staging, methods, duration of follow up, the number of the patients who were successfully down-staged before LT and their outcomes after LT were recorded.
- Being tested
- loco regional therapies for HCC
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
loco regional therapies for HCCProcedure or surgery
29 HCC patients received locoregonal therapy as a bridging therapy for those who were within milan and as downstaging for those were initially beyond milan. The main LRT types used for our patients were TACE and or RFA and microwave ablation
| Study group | Role | What they receive |
|---|---|---|
| HCC patients | 29 HCC patients who had loco regional therapies for HCC were analyzed. Twenty patients met the Milan criteria (68.97%) \& 4 (13.8%) were beyond Milan but met UCSF criteria and 5 were exceeding UCSF criteria (17.2%).All patients underwent preoperative LRTs, The protocol of bridging/down staging, methods, duration of follow up, the number of the patients who were successfully down-staged before LT and their outcomes after LT were recorded. Receives: Procedure: loco regional therapies for HCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological Response ( complete / partial / tumour progression)in the Radiology (CT/ MRI) before transplantation
the success of loco-regional therapy for hepatocellular carcinoma in term of radiological complete or partial response in the last spiral triphasic abdominal CT and /or MRI before transpalantation
Measured: 3 months
Secondary outcomes (1)
the degree of accuracy between the last CT/ MRI and the pathology of explant in term of number , size and ablation (complete necrosis ) for HCC
- presence of viable tumour tissue in the explant pathology,
- mictro vascular invasion
- capsular or lymph node invasion the degree of accuracy between the last CT/ MRI and the pathology of explant
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Retrospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iman Fawzy Montasser, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990351
- Sponsor's protocol ID
- HCC and liver transplantation
- Status last verified
- Dec 2016
- First submitted
- 4 Dec 2016
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loco-regional Treatment for HCC Patients
- ClinicalTrials.gov ID
- NCT02990351
- Acronym / sponsor ID
- HCC and liver transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 Dec 2016 (estimated)
- 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.
This study aimed to analyze the outcomes of loco-regional treatment prior Living Donor Liver Transplantation in patients with HCC.
Detailed description
50 patients received LDLT at Ain Shams Centre for Organ Transplantation (ASCOT) over 1 year of whom data of 29 HCC patients were analyzed. Twenty patients met the Milan criteria (68.97%) \& 4 (13.8%) were beyond Milan but met UCSF criteria and 5 were exceeding UCSF criteria (17.2%).All patients underwent preoperative LRTs, The protocol of bridging/down staging, methods, duration of follow up, the number of the patients who were successfully down-staged before LT and their outcomes after LT were recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCC patients | – | Procedure: loco regional therapies for HCC29 HCC patients who had loco regional therapies for HCC were analyzed. Twenty patients met the Milan criteria (68.97%) \& 4 (13.8%) were beyond Milan but met UCSF criteria and 5 were exceeding UCSF criteria (17.2%).All patients underwent preoperative LRTs, The protocol of bridging/down staging, methods, duration of follow up, the number of the patients who were successfully down-staged before LT and their outcomes after LT were recorded. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Egyptian patients prepared for living donor liver transplantation , at Ain Shams Centre for Organ Transplantation (ASCOT) , Cairo Egypt
Key inclusion criteria (2 listed)
- Adult patients 18-65 years
- Patients transplanted for HCC within Milan and UCSF criteria who underwent pre transplant bridge or down staging treatment for HCC
Key exclusion criteria (3 listed)
- Tumor progression on the waiting list
- Vascular invasion by imaging studies
- Extrahepatic or lymph node metastasis
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 |
|---|---|---|
| loco regional therapies for HCC29 HCC patients received locoregonal therapy as a bridging therapy for those who were within milan and as downstaging for those were initially beyond milan. The main LRT types used for our patients were TACE and or RFA and microwave ablation | Procedure or surgery | HCC patients |
Primary outcome
Radiological Response ( complete / partial / tumour progression)in the Radiology (CT/ MRI) before transplantation
Time frame: 3 months
the success of loco-regional therapy for hepatocellular carcinoma in term of radiological complete or partial response in the last spiral triphasic abdominal CT and /or MRI before transpalantation
1 secondary outcome
the degree of accuracy between the last CT/ MRI and the pathology of explant in term of number , size and ablation (complete necrosis ) for HCC
Time frame: 3 months
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 13 Dec 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma (HCC) and Living Donor Liver Transplantation, run by Ain Shams University.
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 2 inclusion and 3 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 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Radiological Response ( complete / partial / tumour progression)in the Radiology (CT/ MRI) before transplantation (time frame: 3 months). 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 13 Dec 2016.