LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection

Neoplasm Metastasis Clinical Trial

— LIVACOR  

Official title:

LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05138094
• Other study ID #: NP3969
• Status: Recruiting
• Phase: N/A
• Start date: August 6, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: July 2022
• Source: Fondazione Poliambulanza Istituto Ospedaliero
• Contact: Jasper Sijberden, MD
• Phone: 0031630150451
• Email: jasper.sijberden[@]poliambulanza.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Colorectal Neoplasms Malignant
• Neoplasm Metastasis
• Neoplasms

Intervention

Procedure:
• Minimally invasive simultaneous resection
One minimally invasive surgical procedure wherein both the primary colorectal carcinoma and the liver metastases are removed.
• Minimally invasive two-stage resection
Two minimally invasive surgical procedures wherein the primary colorectal carcinoma and the liver metastases are removed

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg
Belgium	General Hospital Groeninge	Kortrijk	West Flanders
France	Antoine-Béclère Hospital	Paris	Île-de-France
Germany	Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie	Saarbrücken	Saarland
Italy	Ospedali Riuniti	Ancona	Marche
Italy	Azienda USL di Bologna	Bologna	Emilia-Romagna
Italy	Fondazione Poliambulanza Istituto Ospedaliero	Brescia	Lombardy
Italy	San Raffaele University Hospital	Milan	Lombardy
Italy	Azienda Ospedaliero-Universitaria di Modena	Modena	Emilia-Romagna
Italy	Federico II University Hospital	Naples	Calabria
Italy	University Hospital Padova	Padova	Veneto
Italy	Parma University Hospital	Parma	Emilia-Romagna
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma	Lazio
Italy	Mauriziano Umberto I Hospital	Turin	Piemonte
Luxembourg	Centre Hospitalier du Luxembourg	Luxembourg
Netherlands	Amsterdam UMC	Amsterdam	Noord-Holland
Netherlands	Maastricht University Medical Center	Maastricht	Limburg
Norway	Oslo University Hospital	Oslo	Østlandet
Russian Federation	Moscow Clinical Scientific Center	Moscow	Moscow Oblast
Spain	Hospital del Mar	Barcelona	Catalonia
Spain	University of Navarrra Hospital (Clinica Universitaria)	Pamplona	Navarre
United Kingdom	University Hospital Birmingham NHS Foundation Trust	Birmingham	West Midlands
United Kingdom	Liverpool University Hospitals NHS Foundation Trust	Liverpool	Northwest England
United Kingdom	King's College Hospital NHS Trust	London	Southeast England
United Kingdom	Manchester University NHS Foundation Trust	Manchester	North West England
United Kingdom	Newcastle-upon-Tyne Hospitals NHS Trust	Newcastle	Northeast England
United Kingdom	University Hospital Plymouth NHS Trust	Plymouth	Southwest England
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton	South East England

Sponsors (28)

Lead Sponsor

Collaborator

Fondazione Poliambulanza Istituto Ospedaliero

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Assistance Publique - Hôpitaux de Paris, Azienda Ospedaliero-Universitaria di Modena, Azienda Usl di Bologna, Centre Hospitalier du Luxembourg, Federico II University, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, General Hospital Groeninge, Hospital del Mar, King's College Hospital NHS Trust, Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie, Liverpool University Hospitals NHS Foundation Trust, Maastricht University Medical Center, Manchester University NHS Foundation Trust, Mauriziano Umberto I Hospital, Moscow Clinical Scientific Center, Newcastle-upon-Tyne Hospitals NHS Trust, Oslo University Hospital, Ospedali Riuniti Ancona, Parma University Hospital, San Raffaele University Hospital, Italy, University Hospital Birmingham NHS Foundation Trust, University Hospital Padova, University Hospital Plymouth NHS Trust, University Hospital Southampton NHS Foundation Trust, University of Navarrra Hospital (Clinica Universitaria), Ziekenhuis Oost-Limburg

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Luxembourg,  Netherlands,  Norway,  Russian Federation,  Spain,  United Kingdom, 

References & Publications (4)

Boudjema K, Locher C, Sabbagh C, Ortega-Deballon P, Heyd B, Bachellier P, Métairie 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	R0 resection margin	Proportion of patients in whom a microscopically radical resection of both the primary colorectal carcinoma and the liver metastases was performed.	30 days postoperatively
Secondary	Length of hospital stay	The length of hospital stay for the surgical procedure(s)	30 days postoperatively
Secondary	Activity tracking using Fitbit™	A patient's functional recovery will also be assessed using the Fitbit smartwatch.	14 days pre-operatively and 60 days postoperatively
Secondary	Intraoperative blood loss	Intraoperative blood loss in milliliters	During the surgical procedure
Secondary	Operative time	Operative time in minutes	Operative time from incision until last suture
Secondary	Morbidity	Morbidity related to the surgical procedure(s)	90-days postoperatively
Secondary	Postoperative bile leakage	Bile leakage occurring after the liver resection	90-days postoperatively
Secondary	Postoperative anastomotic leakage	Anastomotic leakage occurring after the colorectal resection	90-days postoperatively
Secondary	Conversion to open surgery	Intra-operative conversion to an open or hand-assisted procedure	During the surgical procedure
Secondary	Readmission rate	Proportion of patients who is unexpectedly readmitted after the surgical procedure(s)	90-days postoperatively
Secondary	Health-Related Quality of Life	The physical, social and emotional well-being of the patient; assessed using the EuroQol 5d and European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 instruments.	1 year postoperatively
Secondary	Reasons for delay of discharge after functional recovery	All reasons that may cause delay in discharge after the patient has recovered functionally, such as administrative reasons, patient confidence, logistics problems, etc.	30 days postoperatively
Secondary	Hospital and societal costs	All costs that are associated with the operation, including in-hospital costs and out of hospital costs, such as home care, work absence, etc.	1 year postoperatively
Secondary	Three and five-year recurrence free survival	The proportion of patients which is free of recurrence of the malignant disease after resection of both the primary colorectal carcinoma and the liver metastases.	5 years postoperatively
Secondary	Three and five-year overall survival	The proportion of patients which is alive after resection of both the primary colorectal carcinoma and the liver metastases.	5 years postoperatively