Colorectal Neoplasms Malignant, Neoplasm Metastasis
Conditions
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.
Interventions
PROCEDUREMinimally invasive simultaneous resection
One minimally invasive surgical procedure wherein both the primary colorectal carcinoma and the liver metastases are removed.
PROCEDUREMinimally invasive two-stage resection
Two minimally invasive surgical procedures wherein the primary colorectal carcinoma and the liver metastases are removed
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University Hospital Southampton NHS Foundation Trust
University Hospital Birmingham NHS Foundation Trust
Liverpool University Hospitals NHS Foundation Trust
King's College Hospital NHS Trust
Manchester University NHS Foundation Trust
Newcastle-upon-Tyne Hospitals NHS Trust
University Hospital Plymouth NHS Trust
Mauriziano Umberto I Hospital
University Hospital Padova
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
San Raffaele University Hospital, Italy
Ospedali Riuniti Ancona
Azienda Usl di Bologna
Azienda Ospedaliero-Universitaria di Modena
Federico II University
Parma University Hospital
Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie
Maastricht University Medical Center
University of Navarrra Hospital (Clinica Universitaria)
Hospital del Mar
Assistance Publique - Hôpitaux de Paris
Oslo University Hospital
Ziekenhuis Oost-Limburg
General Hospital Groeninge
Moscow Clinical Scientific Center
Centre Hospitalier du Luxembourg
Fondazione Poliambulanza Istituto Ospedaliero
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to functional recovery | Expected average of 4 to 12 days postoperatively | A patient is considered functionally recovered from a surgical procedure when several pre-specified criteria have been met. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | 30 days postoperatively | The length of hospital stay for the surgical procedure(s) |
| Activity tracking using Fitbit™ | 14 days pre-operatively and 60 days postoperatively | A patient's functional recovery will also be assessed using the Fitbit smartwatch. |
| Intraoperative blood loss | During the surgical procedure | Intraoperative blood loss in milliliters |
| Operative time | Operative time from incision until last suture | Operative time in minutes |
| Morbidity | 90-days postoperatively | Morbidity related to the surgical procedure(s) |
| Postoperative bile leakage | 90-days postoperatively | Bile leakage occurring after the liver resection |
| Postoperative anastomotic leakage | 90-days postoperatively | Anastomotic leakage occurring after the colorectal resection |
| R0 resection margin | 30 days postoperatively | Proportion of patients in whom a microscopically radical resection of both the primary colorectal carcinoma and the liver metastases was performed. |
| Readmission rate | 90-days postoperatively | Proportion of patients who is unexpectedly readmitted after the surgical procedure(s) |
| Health-Related Quality of Life | 1 year postoperatively | 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. |
| Reasons for delay of discharge after functional recovery | 30 days postoperatively | All reasons that may cause delay in discharge after the patient has recovered functionally, such as administrative reasons, patient confidence, logistics problems, etc. |
| Hospital and societal costs | 1 year postoperatively | All costs that are associated with the operation, including in-hospital costs and out of hospital costs, such as home care, work absence, etc. |
| Three and five-year recurrence free survival | 5 years postoperatively | 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. |
| Three and five-year overall survival | 5 years postoperatively | The proportion of patients which is alive after resection of both the primary colorectal carcinoma and the liver metastases. |
| Conversion to open surgery | During the surgical procedure | Intra-operative conversion to an open or hand-assisted procedure |
Countries
Belgium, France, Germany, Italy, Luxembourg, Netherlands, Norway, Russia, Spain, United Kingdom
Contacts
Primary ContactJasper Sijberden, MD
Backup ContactProfessor Mohammed Abu Hilal, MD PhD
Outcome results
None listed