NCT05723705

Brief Summary

LIVEROBOT is a collaboration of high-volume liver surgical centers in Europe (≥60 liver resections per year), supported by the European-African Hepato-Pancreato-Biliary Association Education Committee (E-AHPBA), and the European Registry of Minimally Invasive Liver Surgery (E-MILS) aiming to support the step-up implementation and safety of advanced surgical expertise of robotic liver surgery (RLS) on a European basis. The LIVEROBOT training program aims to promote the safe implementation of RLS throughout Europe. The data from all patients operated on during a surgeons' participation in the training program will be prospectively gathered allowing for learning curve and outcome analyses.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

2.7 years

First QC Date

January 25, 2023

Last Update Submit

March 24, 2023

Conditions

Liver DiseasesLiver NeoplasmLiver CancerLiver MetastasesBiliary Tract CancerBiliary Tract NeoplasmsBiliary Tract Diseases

Outcome Measures

Primary Outcomes (1)

  • Textbook Outcome in Liver Surgery (TOLS)

    TOLS is a novel composite measure that captures the most desirable surgical outcomes into a single indicator and is defined as the absence of intraoperative incidents of grade ≥ 2 (defined according to the Oslo classification), postoperative bile leakage of grade B or C (according to the severity grading of the International Study Group of Liver Surgery), Clavien-Dindo ≥ Grade 3 complications, 30-day readmission, in-hospital mortality and the presence of R0 resection margin.

    30 days

Secondary Outcomes (8)

  • CUSUM operative time (Learning curve)

    After completion of 50 minor and 50 major robotic liver surgery cases per surgeon

  • Textbook Outcome in Liver Surgery + (TOLS+)

    30 days

  • Performance grading using the modified OSATS score

    2 years (expected)

  • Conversion to open surgery

    at operation completion

  • Estimated operative blood loss

    at operation completion

  • +3 more secondary outcomes

Interventions

European Multicentre Training Program for Robotic Liver SurgeryOTHER

LIVEROBOT is a pan-european multicentre training program for robotic liver surgery involving simulation training, a procedure video-library, on and off-site proctoring, and video-assessment.

Also known as: Robotic Liver Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients are 18 years or above who are eligible to undergo a robotic hepatectomy for accepted indications.

You may qualify if:

  • Age equal or above 18 years
  • Eligible for elective minimally invasive and open hepatectomy for malignant, pre-malignant or benign disease located in the liver or biliary tract
  • Eligible for both minimally invasive and open surgery according to the operating surgeon
  • Fit to undergo the indicated operation according to both the anaesthesiologist and surgeon

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver DiseasesLiver NeoplasmsBiliary Tract NeoplasmsBiliary Tract Diseases

Condition Hierarchy (Ancestors)

Digestive System DiseasesDigestive System NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Rutger-Jan Swijnenburg, MD PhD

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    PRINCIPAL INVESTIGATOR

  • Jeroen Hagendoorn, MD PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

  • Mathieu d'Hondt, MD PhD

    AZ Groeninge

    PRINCIPAL INVESTIGATOR

  • Mohammed Abu Hilal, MD PhD

    Poliambulanza Foundation Hospital Brescia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriela Pilz da Cunha, MD

CONTACT

020 444 4444g.pilzdacunha@amsterdamumc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 25, 2023

First Posted

February 13, 2023

Study Start

April 1, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

March 27, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share