BReLLS: A Prospective Belgian Registry on Laparoscopic Liver Surgery

Laparoscopic Liver Surgery Clinical Trial

— BReLLS  

Official title:

BReLLS: A Prospective Belgian Registry on Laparoscopic Liver Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03175419
• Other study ID #: B670201627155
• Status: Completed
• Start date: February 16, 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: December 31, 2022
• Est. primary completion date: March 31, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Laparoscopic Liver Surgery

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent	East Flanders

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Medtronic

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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: 10.1080/0001 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Clavien-dindo grade IV	Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management	24 month
Primary	Clavien-dindo grade V	Death of a patient	24 month
Secondary	Mortality	Incidence	24 month
Secondary	Evolution of the laparoscopic approach	Comparison between open and lap procedures in the same center	24 month
Secondary	Assessment of tumor margins	Comparison between R0 and R1 margins	24 month
Secondary	Outcome in HCC and CRLM	Overall and disease free survival calculation for the specific above mentioned pathologies	24 month