NCT05138094

Brief Summary

The LIVACOR - Trial is a European wide, randomized controlled, open-label, multicenter trial. Patients with synchronous colorectal liver metastases (CRLMs) and primary colorectal tumor are considered eligible and will be randomized between minimally invasive (MI) combined or staged colorectal resection (all colectomies, including high anterior resection) and liver resection of up to three segments.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
10 countries

28 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 30, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

2.1 years

First QC Date

November 5, 2021

Last Update Submit

July 22, 2022

Conditions

Colorectal Neoplasms MalignantNeoplasm Metastasis

Outcome Measures

Primary Outcomes (1)

  • Time to functional recovery

    A patient is considered functionally recovered from a surgical procedure when several pre-specified criteria have been met.

    Expected average of 4 to 12 days postoperatively

Secondary Outcomes (15)

  • R0 resection margin

    30 days postoperatively

  • Length of hospital stay

    30 days postoperatively

  • Activity tracking using Fitbit™

    14 days pre-operatively and 60 days postoperatively

  • Intraoperative blood loss

    During the surgical procedure

  • Operative time

    Operative time from incision until last suture

  • +10 more secondary outcomes

Study Arms (2)

Minimally invasive two-stage resection

ACTIVE COMPARATOR

Minimally invasive resection of the primary colorectal carcinoma and liver metastases in two stages. The liver metastases or the colorectal carcinoma can be resected during the first surgical procedure.

Procedure: Minimally invasive two-stage resection

Minimally invasive simultaneous resection

EXPERIMENTAL

Minimally invasive resection of both the primary colorectal carcinoma and the liver metastases in one procedure.

Procedure: Minimally invasive simultaneous resection

Interventions

Minimally invasive simultaneous resectionPROCEDURE

One minimally invasive surgical procedure wherein both the primary colorectal carcinoma and the liver metastases are removed.

Also known as: Minimally invasive combined resection, Minimally invasive synchronous resection
Minimally invasive simultaneous resection
Minimally invasive two-stage resectionPROCEDURE

Two minimally invasive surgical procedures wherein the primary colorectal carcinoma and the liver metastases are removed

Also known as: Minimally invasive sequential resection
Minimally invasive two-stage resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years
  • Diagnosed with primary CRC with resectable synchronous CRLMs (with or without neoadjuvant chemotherapy)\*
  • Elective indication for MI combined or staged colorectal resection (all colectomies, including high anterior resection) and liver resection of up to 3 segments with a maximum of 2 separate liver resections. The MI two-staged approach includes both the conventional strategy (first resection of primary colorectal tumor followed by liver resection for CRLMs) and liver-first strategy (first CRLMs resection followed by resection of colorectal primary tumor). Patients undergoing bilobar resections are eligible (if 3 or fewer segments are resected)
  • BMI between and including 18-35
  • Patients with American Society of Anesthesiologists (ASA) physical status I-III and the American College of Surgeons national surgical quality improvement project (ACS NSQIP) universal surgical risk score of ≤ 50% for serious complications
  • In case of neoadjuvant chemotherapy, time interval between last chemotherapy cycle and (first) surgery should be 4-6 weeks.

You may not qualify if:

  • Inability to give (written) informed consent.
  • Patients requiring a planned temporarily or permanent stoma after colorectal resection (all colectomies, including high anterior resection). Patients who will receive an unplanned stoma intraoperatively, will be analysed according to their initial treatment assignment.
  • Patients requiring multivisceral colorectal resection (all colectomies, including high anterior resection).
  • Indication for MI combined or staged low anterior resection, total mesorectal excision or abdominoperineal resection and liver resection of four or more segments (i.e., hemihepatectomy or more extensive resections).
  • Patients with peritoneal metastases.
  • Patients with ASA physical status IV-V and ACS NSQIP surgical risk score of \> 50% for serious complications.
  • Repeat open hepatectomy
  • Surgical history of colorectal- or liver resection for neoplastic disease
  • Surgical history of major or complicated open abdominal surgery
  • Indication for concurrent thermal ablation
  • Medical history of thermal ablation of liver for malignancy
  • Unresectable extrahepatic metastases
  • Pre-operatively reconstruction of vessels/bile ducts is deemed necessary

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

NOT YET RECRUITING

General Hospital Groeninge

Kortrijk, West Flanders, 8500, Belgium

RECRUITING

Antoine-Béclère Hospital

Paris, Île-de-France Region, 92140, France

NOT YET RECRUITING

Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie

Saarbrücken, Saarland, 66119, Germany

RECRUITING

Federico II University Hospital

Naples, Calabria, 80131, Italy

NOT YET RECRUITING

Azienda USL di Bologna

Bologna, Emilia-Romagna, 40124, Italy

RECRUITING

Azienda Ospedaliero-Universitaria di Modena

Modena, Emilia-Romagna, 41125, Italy

NOT YET RECRUITING

Parma University Hospital

Parma, Emilia-Romagna, 43126, Italy

NOT YET RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, 00168, Italy

RECRUITING

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, Lombardy, 25124, Italy

RECRUITING

San Raffaele University Hospital

Milan, Lombardy, 20132, Italy

NOT YET RECRUITING

Mauriziano Umberto I Hospital

Turin, Piedmont, 10128, Italy

NOT YET RECRUITING

Ospedali Riuniti

Ancona, The Marches, 60126, Italy

NOT YET RECRUITING

University Hospital Padova

Padua, Veneto, 35128, Italy

RECRUITING

Centre Hospitalier du Luxembourg

Luxembourg, L-1210, Luxembourg

RECRUITING

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

NOT YET RECRUITING

Amsterdam UMC

Amsterdam, North Holland, 1081 HV, Netherlands

RECRUITING

Oslo University Hospital

Oslo, Østlandet, N-0424, Norway

RECRUITING

Moscow Clinical Scientific Center

Moscow, Moscow Oblast, 111123, Russia

RECRUITING

Hospital del Mar

Barcelona, Catalonia, 08003, Spain

RECRUITING

University of Navarrra Hospital (Clinica Universitaria)

Pamplona, Navarre, 31008, Spain

NOT YET RECRUITING

Manchester University NHS Foundation Trust

Manchester, North West England, M13 9WL, United Kingdom

NOT YET RECRUITING

Newcastle-upon-Tyne Hospitals NHS Trust

Newcastle, Northeast England, NE1 4LP, United Kingdom

NOT YET RECRUITING

Liverpool University Hospitals NHS Foundation Trust

Liverpool, Northwest England, L7 8XP, United Kingdom

NOT YET RECRUITING

University Hospital Southampton NHS Foundation Trust

Southampton, South East England, SO16 6YD, United Kingdom

NOT YET RECRUITING

King's College Hospital NHS Trust

London, Southeast England, SE5 9RS, United Kingdom

NOT YET RECRUITING

University Hospital Plymouth NHS Trust

Plymouth, Southwest England, PL6 8DH, United Kingdom

NOT YET RECRUITING

University Hospital Birmingham NHS Foundation Trust

Birmingham, West Midlands, B15 1NT, United Kingdom

NOT YET RECRUITING

Related Publications (4)

  • van der Poel MJ, Tanis PJ, Marsman HA, Rijken AM, Gertsen EC, Ovaere S, Gerhards MF, Besselink MG, D'Hondt M, Gobardhan PD. Laparoscopic combined resection of liver metastases and colorectal cancer: a multicenter, case-matched study using propensity scores. Surg Endosc. 2019 Apr;33(4):1124-1130. doi: 10.1007/s00464-018-6371-1. Epub 2018 Aug 1.

    PMID: 30069639BACKGROUND

  • Pan L, Tong C, Fu S, Fang J, Gu Q, Wang S, Jiang Z, Juengpanich S, Cai X. Laparoscopic procedure is associated with lower morbidity for simultaneous resection of colorectal cancer and liver metastases: an updated meta-analysis. World J Surg Oncol. 2020 Sep 21;18(1):251. doi: 10.1186/s12957-020-02018-z.

    PMID: 32958079BACKGROUND

  • Boudjema K, Locher C, Sabbagh C, Ortega-Deballon P, Heyd B, Bachellier P, Metairie S, Paye F, Bourlier P, Adam R, Merdrignac A, Tual C, Le Pabic E, Sulpice L, Meunier B, Regimbeau JM, Bellissant E; METASYNC Study group. Simultaneous Versus Delayed Resection for Initially Resectable Synchronous Colorectal Cancer Liver Metastases: A Prospective, Open-label, Randomized, Controlled Trial. Ann Surg. 2021 Jan 1;273(1):49-56. doi: 10.1097/SLA.0000000000003848.

    PMID: 32209911BACKGROUND

  • Gavriilidis P, Sutcliffe RP, Hodson J, Marudanayagam R, Isaac J, Azoulay D, Roberts KJ. Simultaneous versus delayed hepatectomy for synchronous colorectal liver metastases: a systematic review and meta-analysis. HPB (Oxford). 2018 Jan;20(1):11-19. doi: 10.1016/j.hpb.2017.08.008. Epub 2017 Sep 7.

    PMID: 28888775BACKGROUND

MeSH Terms

Conditions

Colonic NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Professor Mohammed Abu Hilal, MD PhD

    Fondazione Poliambulanza Istituto Ospedaliero

    STUDY CHAIR

Central Study Contacts

Jasper Sijberden, MD

CONTACT

0031630150451jasper.sijberden@poliambulanza.it

Professor Mohammed Abu Hilal, MD PhD

CONTACT

abuhilal9@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2021

First Posted

November 30, 2021

Study Start

August 6, 2021

Primary Completion

September 1, 2023

Study Completion

September 1, 2024

Last Updated

July 25, 2022

Record last verified: 2022-07

Locations

BE(2)FR(1)DE(1)NO(1)NL(2)RU(1)IT(10)GB(7)LU(1)ES(2)