BReLLS: A Prospective Belgian Registry on Laparoscopic Liver Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Clavien-dindo grade III A and B
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.)
排除标准
- 未提供
结局指标
主要结局
Clavien-dindo grade III A and B
时间窗: 24 month
Requiring surgical, endoscopic or radiological intervention, intervention not (A) under general anesthesia; intervention under general anesthesia (B)
Clavien-dindo grade IV
时间窗: 24 month
Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management
Clavien-dindo grade V
时间窗: 24 month
Death of a patient
Clavien-dindo grade I
时间窗: 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
时间窗: 24 month
Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.
次要结局
- Mortality(24 month)
- Assessment of tumor margins(24 month)
- Outcome in HCC and CRLM(24 month)
- Evolution of the laparoscopic approach(24 month)
研究者
AHHK
Prof. Dr. Roberto Troisi
University Hospital, Ghent