BReLLS: A Prospective Belgian Registry on Laparoscopic Liver Surgery (BReLLS)

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Liver Surgery

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 Type: Observational
• Enrollment (Actual): 1500

Contacts and Locations

Study Locations

• Belgium
  • East Flanders
    • Ghent, East Flanders, Belgium, 9000
      • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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.)

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Medtronic

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2016
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: May 31, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: laparoscopic liver resection
• Other Study ID Numbers: B670201627155

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No