BReLLS: A Prospective Belgian Registry on Laparoscopic Liver Surgery

NCT03175419 | Completed DMC

• 1 other identifier: B670201627155
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Liver Surgery

Keywords

laparoscopic liver resection

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Mortality

  24 month

• Evolution of the laparoscopic approach

  24 month

• Assessment of tumor margins

  24 month

• Outcome in HCC and CRLM

  24 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Medtronic: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, East Flanders, 9000, Belgium

Location

Related 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: 10.1080/00015458.2016.1202478. Epub 2016 Aug 19.

  PMID: 27541973 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Roberto Troisi

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: June 5, 2017
• Study Start: February 16, 2016
• Primary Completion: March 31, 2020
• Study Completion: December 31, 2022
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)