Open vs Laparoscopic Liver Surgery for Colorectal Liver Metastases (LapOpHuva)

Virgen de la Arrixaca University Clinical Hospital (HCUVA)

Status: Completed

Conditions: Laparoscopic Liver Resection; Colorectal Liver Metastasis

Treatments: Procedure: Liver resection

Study type: Interventional

Funder types: Other

Identifiers

NCT02727179

HUVA-0515

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Laparoscopic group

Experimental group

Description:

Liver resection performed by laparoscopic approach

Treatment:

Procedure: Liver resection

Open group

Active Comparator group

Description:

Liver resection performed by open approach

Treatment:

Procedure: Liver resection