Laparoscopic Liver SurgeryBReLLSNCT03175419
BReLLS: A Prospective Belgian Registry on Laparoscopic Liver Surgery
An observational study of Laparoscopic Liver Surgery, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Setting up a Prospective Belgian National Registry of patients undergoing minimally invasive liver resections will allow the constitution of a national network able to get updated information on indication and results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Liver Surgery
- How many people
- 1,500 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Feb 2016to 31 Dec 2022
- How long will I take part?
- 2 Years
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients will be observed from the time of recruitment and throughout the hospital stay and will be collected information on vital status until discharge and planned follow-up. There is a minimum of 1-year follow-up required. Upon the evolution of patients inclusion and the available resources, we will consider to extend the FU time especially for oncological issues.
Who may be able to join
- Patients undergoing hepatic resection with minimally invasive approach (laparoscopic and robotic assisted)
- minimum age of > or = 18 years
- Signed informed consent.
- Cysts deroofing
- Laparoscopic resections combined to ablation procedures
- Ablation procedures (RFA, MWA, other)
Who cannot join
- Laparoscopic staging procedures of the liver with/without intraoperative ultrasonography and/or biopsy.
- Solely others therapeutic procedure of the liver (RFA, MWA, PV ligation, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Setting up a Prospective Belgian National Registry of patients undergoing minimally invasive liver resections will allow the constitution of a national network able to get updated information on indication and results. Data will be of great importance for additional scientific projects aimed to clarify the role of minimally invasive approach in surgical liver pathology, especially malignancies.
Read the detailed description
During recent years we saw over the world a consistent growth of laparoscopic liver surgery (LLS), essentially due to progress of the surgical techniques, technology and diagnostic imaging. During the Louisville conference on LLS (2008) the technique was thoroughly described and defined. One of the most important statements was the promotion of national registries, taking into account the logistics and feasibility problems of randomized trials in this setting. The main purpose to hold a Belgian national registry is to define the role of LLS in our country, looking for short and long-term outcomes, especially in case of liver tumors.
In Belgium approximately 1000 liver resections are performed each year, however, the rate and results of LLS are unknown. The prospective data collection will highlight the role and incidence of LLS. Eventually, the registry will serve as support for scientific projects on different topics.
The evolution of the national practice will be measured by looking to the ratio between laparoscopic and open procedures registered in the electronic CRF (eCRF) in a single center during a time period.
The registration of additional parameters (as per below) will be necessary for comparing outcomes between conventional and laparoscopic techniques.
The registered cases will be recorded prospectively and consecutively.
- Conditions
- Laparoscopic Liver Surgery
- Keywords
- laparoscopic liver resection
What is being measured
The primary outcome is the main question the study is designed to answer.
Clavien-dindo grade I
Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside.
Measured: 24 month
Clavien-dindo grade II
Requiring pharmacological treatment with drugs other than such allowed for grade I complications.
Blood transfusions and total parenteral nutrition are also included.
Measured: 24 month
Clavien-dindo grade III A and B
Requiring surgical, endoscopic or radiological intervention, intervention not (A) under general anesthesia; intervention under general anesthesia (B)
Measured: 24 month
Clavien-dindo grade IV
Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management
Measured: 24 month
Clavien-dindo grade V
Death of a patient
Measured: 24 month
Secondary outcomes (4)
Mortality
Incidence
Measured: 24 month
Evolution of the laparoscopic approach
Comparison between open and lap procedures in the same center
Measured: 24 month
Assessment of tumor margins
Comparison between R0 and R1 margins
Measured: 24 month
Outcome in HCC and CRLM
Overall and disease free survival calculation for the specific above mentioned pathologies
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start16 Feb 2016
- Primary completion31 Mar 2020
- Study completion31 Dec 2022
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 Laparoscopic Liver SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Prospective
- Enrolment
- 1,500 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, AHHK, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175419
- Sponsor's protocol ID
- B670201627155
- Acronym
- BReLLS
- Status last verified
- Aug 2023
- First submitted
- 23 May 2017
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Tomassini F, Scuderi V, Berardi G, Dili A, D'Hondt M, Sergeant G, Hubert C, Huysentruyt F, Berrevoet F, Lucidi V, Troisi RI. The practice of laparoscopic liver surgery in Belgium: a national survey. Acta Chir Belg. 2017 Feb;117(1):15-20. doi: 10.1080/00015458.2016.1202478. Epub 2016 Aug 19.
PubMed 27541973
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BReLLS: A Prospective Belgian Registry on Laparoscopic Liver Surgery
- ClinicalTrials.gov ID
- NCT03175419
- Acronym / sponsor ID
- BReLLS / B670201627155
- Conditions
- Laparoscopic Liver Surgery
- Keywords
- laparoscopic liver resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 16 Feb 2016 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Jun 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.
Setting up a Prospective Belgian National Registry of patients undergoing minimally invasive liver resections will allow the constitution of a national network able to get updated information on indication and results. Data will be of great importance for additional scientific projects aimed to clarify the role of minimally invasive approach in surgical liver pathology, especially malignancies.
Detailed description
During recent years we saw over the world a consistent growth of laparoscopic liver surgery (LLS), essentially due to progress of the surgical techniques, technology and diagnostic imaging. During the Louisville conference on LLS (2008) the technique was thoroughly described and defined. One of the most important statements was the promotion of national registries, taking into account the logistics and feasibility problems of randomized trials in this setting. The main purpose to hold a Belgian national registry is to define the role of LLS in our country, looking for short and long-term outcomes, especially in case of liver tumors.
In Belgium approximately 1000 liver resections are performed each year, however, the rate and results of LLS are unknown. The prospective data collection will highlight the role and incidence of LLS. Eventually, the registry will serve as support for scientific projects on different topics.
The evolution of the national practice will be measured by looking to the ratio between laparoscopic and open procedures registered in the electronic CRF (eCRF) in a single center during a time period.
The registration of additional parameters (as per below) will be necessary for comparing outcomes between conventional and laparoscopic techniques.
The registered cases will be recorded prospectively and consecutively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients will be observed from the time of recruitment and throughout the hospital stay and will be collected information on vital status until discharge and planned follow-up. There is a minimum of 1-year follow-up required. Upon the evolution of patients inclusion and the available resources, we will consider to extend the FU time especially for oncological issues.
Key inclusion criteria (6 listed)
- Patients undergoing hepatic resection with minimally invasive approach (laparoscopic and robotic assisted)
- minimum age of > or = 18 years
- Signed informed consent.
- Cysts deroofing
- Laparoscopic resections combined to ablation procedures
Key exclusion criteria (2 listed)
- Laparoscopic staging procedures of the liver with/without intraoperative ultrasonography and/or biopsy.
- Solely others therapeutic procedure of the liver (RFA, MWA, PV ligation, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clavien-dindo grade I
Time frame: 24 month
Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside.
Clavien-dindo grade II
Time frame: 24 month
Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.
Clavien-dindo grade III A and B
Time frame: 24 month
Requiring surgical, endoscopic or radiological intervention, intervention not (A) under general anesthesia; intervention under general anesthesia (B)
Clavien-dindo grade IV
Time frame: 24 month
Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management
Clavien-dindo grade V
Time frame: 24 month
Death of a patient
4 secondary outcomes
Mortality
Time frame: 24 month
Evolution of the laparoscopic approach
Time frame: 24 month
Assessment of tumor margins
Time frame: 24 month
Outcome in HCC and CRLM
Time frame: 24 month
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 1 Sep 2023.
- Results publication: PubMed 27541973Tomassini F, Scuderi V, Berardi G, Dili A, D'Hondt M, Sergeant G, Hubert C, Huysentruyt F, Berrevoet F, Lucidi V, Troisi RI. The practice of laparoscopic liver surgery in Belgium: a national survey. Acta Chir Belg. 2017 Feb;117(1):15-20. doi: 10.1080/00015458.2016.1202478. Epub 2016 Aug 19.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Liver Surgery, run by University Hospital, Ghent at 1 site in Belgium.
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 6 inclusion and 2 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 1 Sep 2023. 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 Belgium. 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?
Clavien-dindo grade I (time frame: 24 month). The study lists 5 primary outcomes in all. 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 NCT03175419, 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 1 Sep 2023.