Clinical trial NCT05138094: LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection
Official title: LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Neoplasms Malignant
Neoplasm Metastasis
Lead sponsor: Fondazione Poliambulanza Istituto Ospedaliero
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: University Hospital Southampton NHS Foundation Trust
name: University Hospital Birmingham NHS Foundation Trust
name: Liverpool University Hospitals NHS Foundation Trust
name: King's College Hospital NHS Trust
name: Manchester University NHS Foundation Trust
name: Newcastle-upon-Tyne Hospitals NHS Trust
name: University Hospital Plymouth NHS Trust
name: Mauriziano Umberto I Hospital
name: University Hospital Padova
name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: San Raffaele University Hospital, Italy
name: Ospedali Riuniti Ancona
name: Azienda Usl di Bologna
name: Azienda Ospedaliero-Universitaria di Modena
name: Federico II University
name: Parma University Hospital
name: Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie
name: Maastricht University Medical Center
name: University of Navarrra Hospital (Clinica Universitaria)
name: Hospital del Mar
name: Assistance Publique - Hôpitaux de Paris
name: Oslo University Hospital
name: Ziekenhuis Oost-Limburg
name: General Hospital Groeninge
name: Moscow Clinical Scientific Center
name: Centre Hospitalier du Luxembourg
First posted: 2021-11-30
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* ≥ 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Time to functional recovery
timeFrame: Expected average of 4 to 12 days postoperatively
Secondary outcomes:
measure: R0 resection margin
timeFrame: 30 days postoperatively
measure: Length of hospital stay
timeFrame: 30 days postoperatively
measure: Activity tracking using Fitbit™
timeFrame: 14 days pre-operatively and 60 days postoperatively
measure: Intraoperative blood loss
timeFrame: During the surgical procedure
measure: Operative time
timeFrame: Operative time from incision until last suture
measure: Morbidity
timeFrame: 90-days postoperatively
measure: Postoperative bile leakage
timeFrame: 90-days postoperatively
measure: Postoperative anastomotic leakage
timeFrame: 90-days postoperatively
measure: Conversion to open surgery
timeFrame: During the surgical procedure
measure: Readmission rate
timeFrame: 90-days postoperatively
measure: Health-Related Quality of Life
timeFrame: 1 year postoperatively
measure: Reasons for delay of discharge after functional recovery
timeFrame: 30 days postoperatively
measure: Hospital and societal costs
timeFrame: 1 year postoperatively
measure: Three and five-year recurrence free survival
timeFrame: 5 years postoperatively
measure: Three and five-year overall survival
timeFrame: 5 years postoperatively
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
city: Kortrijk
country: Belgium
facility: General Hospital Groeninge
state: West Flanders
city: Paris
country: France
facility: Antoine-Béclère Hospital
state: Île-de-France
city: Saarbrücken
country: Germany
facility: Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie
state: Saarland
city: Naples
country: Italy
facility: Federico II University Hospital
state: Calabria
city: Bologna
country: Italy
facility: Azienda USL di Bologna
state: Emilia-Romagna
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena
state: Emilia-Romagna
city: Parma
country: Italy
facility: Parma University Hospital
state: Emilia-Romagna
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
state: Lazio
city: Brescia
country: Italy
facility: Fondazione Poliambulanza Istituto Ospedaliero
state: Lombardy
city: Milan
country: Italy
facility: San Raffaele University Hospital
state: Lombardy
city: Ancona
country: Italy
facility: Ospedali Riuniti
state: Marche
city: Turin
country: Italy
facility: Mauriziano Umberto I Hospital
state: Piemonte
city: Padova
country: Italy
facility: University Hospital Padova
state: Veneto
city: Luxembourg
country: Luxembourg
facility: Centre Hospitalier du Luxembourg
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
city: Oslo
country: Norway
facility: Oslo University Hospital
state: Østlandet
city: Moscow
country: Russian Federation
facility: Moscow Clinical Scientific Center
state: Moscow Oblast
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Catalonia
city: Pamplona
country: Spain
facility: University of Navarrra Hospital (Clinica Universitaria)
state: Navarre
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
state: North West England
city: Newcastle
country: United Kingdom
facility: Newcastle-upon-Tyne Hospitals NHS Trust
state: Northeast England
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals NHS Foundation Trust
state: Northwest England
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
state: South East England
city: London
country: United Kingdom
facility: King's College Hospital NHS Trust
state: Southeast England
city: Plymouth
country: United Kingdom
facility: University Hospital Plymouth NHS Trust
state: Southwest England
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham NHS Foundation Trust
state: West Midlands
Study officials:
affiliation: Fondazione Poliambulanza Istituto Ospedaliero
name: Professor Mohammed Abu Hilal, MD PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.