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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05138094
Other study ID # NP3969
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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