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Completed

NCT Number: NCT03175419

BReLLS: A Prospective Belgian Registry on Laparoscopic Liver Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent University Hospital

Ghent, East Flanders, 9000, Belgium

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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)

  4. Clavien-dindo grade IV

    Time frame: 24 month

    Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management

  5. Clavien-dindo grade V

    Time frame: 24 month

    Death of a patient

Secondary outcomes

  1. Mortality

    Time frame: 24 month

    Incidence

  2. Evolution of the laparoscopic approach

    Time frame: 24 month

    Comparison between open and lap procedures in the same center

  3. Assessment of tumor margins

    Time frame: 24 month

    Comparison between R0 and R1 margins

  4. Outcome in HCC and CRLM

    Time frame: 24 month

    Overall and disease free survival calculation for the specific above mentioned pathologies

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Medtronic

Registry information

Acronym: BReLLS

Important dates

Study start
2016
Primary completion
2020
Study completion
2022
First posted
Jun 5, 2017
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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