Open vs Laparoscopic Liver Surgery for Colorectal Liver Metastases

Study Overview
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Brief Summary
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This study evaluates the feasibility of laparoscopic surgery in patients diagnosed with colorectal liver metastases. Half of participants will be operated on by laparoscopic approach and the results obtained will be compared with the results from the other half of patients operated on by open approach.

Detailed Description
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The safety and efficacy of liver surgery in the treatment of colorectal liver metastases are well established for the open approach. It allows good results in terms of complications, disease free survival and overall survival, and for these reasons it has become the gold standard technique in the treatment of colorectal liver metastases. On the contrary, the role of laparoscopic liver resection in this context is not so clear nowadays. Generally, laparoscopic surgery offers some advantages such as less pain, shorter hospital stay and better aesthetic results. But the use of laparoscopic approach in liver surgery is still discussing: two international consensus conferences have been held and no strong conclusions have been made. Furthermore for colorectal liver metastases no randomized trials, comparing both techniques, have been published until now. To assess the feasibility of laparoscopic liver resection for colorectal metastases, the investigators propose this trial in which the patients suitable for laparoscopic approach are randomized to open or laparoscopic group

Official Title
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Prospective and Randomized Study Comparing Open vs Laparoscopic Liver Surgery for Colorectal Liver Metastases

Conditions
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Colorectal Liver Metastasis, Laparoscopic Liver Resection

Intervention / Treatment
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* Procedure: Liver resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with colorectal liver metastases; Patients suitable for surgical treatment; Patients eligible for laparoscopy approach. Exclusion Criteria: Patients with high tumour load: multiples and bilobar colorectal metastases; Patients with big liver metastases or close to major vessels; Patients with oncological contraindications for surgery; Cirrhotic liver Needing for two stage liver resection; Medical or psychiatric condition of the patient that compromises the informed consent authorization; Refusal to participate in the study

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 |
| --- | --- |
| Experimental: Laparoscopic group<br>Liver resection performed by laparoscopic approach | Procedure: Liver resection<br>* The investigators perform an anatomical liver resections or wedge resections depending on tumour's location and tumour's characteristics<br>|
| Active Comparator: Open group<br>Liver resection performed by open approach | Procedure: Liver resection<br>* The investigators perform an anatomical liver resections or wedge resections depending on tumour's location and tumour's characteristics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical operative time | Duration of the surgical intervention | Intraoperative | 
| Blood losses | Blood loss in milliliter | Intraoperative | 
| Transfusion | Number of blood transfusions required during surgical operation | Intraoperative | 
| Hospital stay | Days between surgical operation and hospital discharge | Up to 3 months | 
| Time between surgery and adjuvant chemotherapy | Days between surgical operation and the beginning of adjuvant chemotherapy | Up to 3 months | 
| Mortality |  | 90 days | 
| Morbidity |  | 90 days |