LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection

Study Overview
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Brief Summary
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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.

Official Title
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LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection

Conditions
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Colorectal Neoplasms Malignant, Neoplasm Metastasis

Intervention / Treatment
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* Procedure: Minimally invasive simultaneous resection
* Procedure: Minimally invasive two-stage resection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Minimally invasive two-stage resection<br>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<br>* Two minimally invasive surgical procedures wherein the primary colorectal carcinoma and the liver metastases are removed<br>* Other names: Minimally invasive sequential resection;|
| Experimental: Minimally invasive simultaneous resection<br>Minimally invasive resection of both the primary colorectal carcinoma and the liver metastases in one procedure. | Procedure: Minimally invasive simultaneous resection<br>* One minimally invasive surgical procedure wherein both the primary colorectal carcinoma and the liver metastases are removed.<br>* Other names: Minimally invasive synchronous resection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Length of hospital stay | The length of hospital stay for the surgical procedure(s) | 30 days postoperatively | 
| 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 | 
| Intraoperative blood loss | Intraoperative blood loss in milliliters | During the surgical procedure | 
| Operative time | Operative time in minutes | Operative time from incision until last suture | 
| Morbidity | Morbidity related to the surgical procedure(s) | 90-days postoperatively | 
| Postoperative bile leakage | Bile leakage occurring after the liver resection | 90-days postoperatively | 
| Postoperative anastomotic leakage | Anastomotic leakage occurring after the colorectal resection | 90-days postoperatively | 
| Conversion to open surgery | Intra-operative conversion to an open or hand-assisted procedure | During the surgical procedure | 
| Readmission rate | Proportion of patients who is unexpectedly readmitted after the surgical procedure(s) | 90-days postoperatively | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |