Open vs Laparoscopic Liver Surgery for Colorectal Liver Metastases

Not Applicable

Completed

• Conditions: Laparoscopic Liver Resection; Colorectal Liver Metastasis
• Interventions: Procedure: Liver resection

• Registration Number: NCT02727179
• Lead Sponsor: Hospital Universitario Virgen de la Arrixaca

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

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2016-03-14
• Study First Submitted QC: 2016-03-29
• Study First Posted: 2016-04-04
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-19
• Last Update Posted: 2017-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open group	Liver resection	Liver resection performed by open approach
Laparoscopic group	Liver resection	Liver resection performed by laparoscopic approach

Primary Outcome Measures

Name	Time	Method
Overall survival	1 year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Universitario "Virgen de la Arrixaca"; 🇪🇸 Murcia, Spain