BReLLS: A Prospective Belgian Registry on Laparoscopic Liver Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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BReLLS: A Prospective Belgian Registry on Laparoscopic Liver Surgery

Conditions
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Laparoscopic Liver Surgery

Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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) | 24 month | 
| Clavien-dindo grade IV | Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management | 24 month | 
| Clavien-dindo grade V | Death of a patient | 24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Incidence | 24 month | 
| Evolution of the laparoscopic approach | Comparison between open and lap procedures in the same center | 24 month | 
| Assessment of tumor margins | Comparison between R0 and R1 margins | 24 month | 
| Outcome in HCC and CRLM | Overall and disease free survival calculation for the specific above mentioned pathologies | 24 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic liver resection