Colorectal Liver Metastasis, Laparoscopic Liver Resection
Conditions
Brief summary
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
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
Interventions
PROCEDURELiver resection
The investigators perform an anatomical liver resections or wedge resections depending on tumour's location and tumour's characteristics
Sponsors
Hospital Universitario Virgen de la Arrixaca
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood losses | Intraoperative | Blood loss in milliliter |
| Transfusion | Intraoperative | Number of blood transfusions required during surgical operation |
| Hospital stay | Up to 3 months | Days between surgical operation and hospital discharge |
| Surgical operative time | Intraoperative | Duration of the surgical intervention |
| Mortality | 90 days | — |
| Morbidity | 90 days | — |
| Time between surgery and adjuvant chemotherapy | Up to 3 months | Days between surgical operation and the beginning of adjuvant chemotherapy |
Countries
Spain
Outcome results
None listed