Clinical trial NCT02727179: Open vs Laparoscopic Liver Surgery for Colorectal Liver Metastases
Official title: Prospective and Randomized Study Comparing Open vs Laparoscopic Liver Surgery for Colorectal Liver Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Liver Metastasis
Laparoscopic Liver Resection
Lead sponsor: Hospital Universitario Virgen de la Arrixaca
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: 1 year
Secondary outcomes:
measure: Surgical operative time
timeFrame: Intraoperative
measure: Blood losses
timeFrame: Intraoperative
measure: Transfusion
timeFrame: Intraoperative
measure: Hospital stay
timeFrame: Up to 3 months
measure: Time between surgery and adjuvant chemotherapy
timeFrame: Up to 3 months
measure: Mortality
timeFrame: 90 days
measure: Morbidity
timeFrame: 90 days
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Hospital Universitario "Virgen de la Arrixaca"
Study officials:
affiliation: Hospital Universitario Virgen de la Arrixaca
name: Ricardo Robles Campos, MD; PHD
role: STUDY_CHAIR
References:
citation: Robles-Campos R, Lopez-Lopez V, Brusadin R, Lopez-Conesa A, Gil-Vazquez PJ, Navarro-Barrios A, Parrilla P. Open versus minimally invasive liver surgery for colorectal liver metastases (LapOpHuva): a prospective randomized controlled trial. Surg Endosc. 2019 Dec;33(12):3926-3936. doi: 10.1007/s00464-019-06679-0. Epub 2019 Jan 30.