BReLLS: A Prospective Belgian Registry on Laparoscopic Liver Surgery

NCT ID: NCT03175419

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-16
• Study Completion Date: 2022-12-31

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.

Conditions

Laparoscopic Liver Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

AHHK

Prof. Dr. Roberto Troisi

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ghent University Hospital

Ghent, East Flanders, Belgium

Countries

Belgium

References

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.

Reference Type: RESULT

PMID: 27541973 (View on PubMed)

Other Identifiers

B670201627155

Identifier Type: -

Identifier Source: org_study_id