Hepatocellular CarcinomaNCT06496113
Robotic Versus Laparoscopic Liver Resection for Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by Ente Ospedaliero Cantonale, Bellinzona.
Trial summary
The objective of the study is to investigate the long-term outcomes of minimally invasive liver surgery (robotic vs laparoscopic) for hepatocellular carcinoma patients of stage BCLC 0-A. Data from two tertiary centers for liver surgery will be retrospectively reviewed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Minimally invasive liver resection
- Type of treatment
- Surgery or procedure
- How many people
- 196 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jun 2024
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients underwent minimally invasive liver resection in centers participating in the study
Who may be able to join
- Patients undergoing robotic and laparoscopic resections
- Histology-confirmed HCC of stage BCLC 0-A
- Preserved liver function (Child score A-B)
- Patients >18 years old
Who cannot join
- Hand-assisted procedures
- Non-elective surgery
- Intraoperative switch to locoregional therapies (like radiofrequency or microwave ablation)
- Non-histologically confirmed HCC
- Mixed hepato-cholangiocarcinoma.
About this study
Official title: Recurrence ad Survival After Robotic Versus Laparoscopic Liver Resection in Very-early to Early (BCLC 0-A) Hepatocellular Carcinoma
The objective of the study is to investigate the long-term outcomes of minimally invasive liver surgery (robotic vs laparoscopic) for hepatocellular carcinoma patients of stage BCLC 0-A. Data from two tertiary centers for liver surgery will be retrospectively reviewed. Patients will be divided in two cohorts (robot; laparoscopy). The primary endpoint will be recurrence-free and overall survival; secondary endpoints were incidence, pattern, and treatment of recurrences.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Minimally invasive liver resection
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive liver resectionProcedure or surgery
Patients underwent liver resection either by robotic or laparoscopic approach
| Study group | Role | What they receive |
|---|---|---|
| Robotic liver resections | Not described Receives: Procedure: Minimally invasive liver resection | |
| Laparoscopic liver resection | Not described Receives: Procedure: Minimally invasive liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival
Recurrence was dated at the first HCC detection on follow-up imaging.
Measured: From the date of liver resection until the first documented HCC progression on follow-up imaging, assessed up to 116 months. The Minimum follow-up accepted was of 3 months postoperatively.
Overall survival
Measured: From the date of liver resection until the date of death for any cause or the last follow-up available whichever came first, assessed up to 116 months. The Minimum follow-up accepted was of 3 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study startJan 2014
- Primary completionApr 2024
- Study completionJun 2024
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.
- 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
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Cantonale, Bellinzona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496113
- Sponsor's protocol ID
- 2023-01022 CE 4377
- Other IDs
- 2023
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrence ad Survival After Robotic Versus Laparoscopic Liver Resection in Very-early to Early (BCLC 0-A) Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06496113
- Acronym / sponsor ID
- 2023-01022 CE 4377
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Ente Ospedaliero Cantonale, BellinzonaUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Apr 2024 (actual)
- Study completion
- Jun 2024 (actual)
- First posted
- 11 Jul 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.
The objective of the study is to investigate the long-term outcomes of minimally invasive liver surgery (robotic vs laparoscopic) for hepatocellular carcinoma patients of stage BCLC 0-A. Data from two tertiary centers for liver surgery will be retrospectively reviewed. Patients will be divided in two cohorts (robot; laparoscopy). The primary endpoint will be recurrence-free and overall survival; secondary endpoints were incidence, pattern, and treatment of recurrences.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic liver resections | – | Procedure: Minimally invasive liver resection |
| Laparoscopic liver resection | – | Procedure: Minimally invasive liver resection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients underwent minimally invasive liver resection in centers participating in the study
Key inclusion criteria (4 listed)
- Patients undergoing robotic and laparoscopic resections
- Histology-confirmed HCC of stage BCLC 0-A
- Preserved liver function (Child score A-B)
- Patients >18 years old
Key exclusion criteria (5 listed)
- Hand-assisted procedures
- Non-elective surgery
- Intraoperative switch to locoregional therapies (like radiofrequency or microwave ablation)
- Non-histologically confirmed HCC
- Mixed hepato-cholangiocarcinoma.
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 |
|---|---|---|
| Minimally invasive liver resectionPatients underwent liver resection either by robotic or laparoscopic approach | Procedure or surgery | Laparoscopic liver resection, Robotic liver resections |
Primary outcome
Recurrence-free survival
Time frame: From the date of liver resection until the first documented HCC progression on follow-up imaging, assessed up to 116 months. The Minimum follow-up accepted was of 3 months postoperatively.
Recurrence was dated at the first HCC detection on follow-up imaging.
Overall survival
Time frame: From the date of liver resection until the date of death for any cause or the last follow-up available whichever came first, assessed up to 116 months. The Minimum follow-up accepted was of 3 months postoperatively.
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 11 Jul 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.
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, run by Ente Ospedaliero Cantonale, Bellinzona.
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 4 inclusion and 5 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 11 Jul 2024. 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?
Recurrence-free survival (time frame: From the date of liver resection until the first documented HCC progression on follow-up imaging, assessed up to 116 months. The Minimum follow-up accepted was of 3 months postoperatively.). The study lists 2 primary outcomes in all. 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 11 Jul 2024.