Clinical trial NCT03175419: BReLLS: A Prospective Belgian Registry on Laparoscopic Liver Surgery
Official title: BReLLS: A Prospective Belgian Registry on Laparoscopic Liver Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laparoscopic Liver Surgery
Keywords: laparoscopic liver resection
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2017-06-05
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion criteria:

* 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.)

Primary outcomes:
measure: Clavien-dindo grade I
timeFrame: 24 month
measure: Clavien-dindo grade II
timeFrame: 24 month
measure: Clavien-dindo grade III A and B
timeFrame: 24 month
measure: Clavien-dindo grade IV
timeFrame: 24 month
measure: Clavien-dindo grade V
timeFrame: 24 month
Secondary outcomes:
measure: Mortality
timeFrame: 24 month
measure: Evolution of the laparoscopic approach
timeFrame: 24 month
measure: Assessment of tumor margins
timeFrame: 24 month
measure: Outcome in HCC and CRLM
timeFrame: 24 month
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
state: East Flanders
Study officials:
References:
citation: 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.