Open vs Laparoscopic Liver Surgery for Colorectal Liver Metastases

Colorectal Liver Metastasis Clinical Trial

— LapOpHuva  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727179
• Other study ID #: HUVA-0515
• Status: Completed
• Phase: N/A
• First received: March 14, 2016
• Last updated: December 19, 2017
• Start date: February 2005
• Est. completion date: March 2017

Study information

• Verified date: December 2017
• Source: Hospital Universitario Virgen de la Arrixaca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Liver Metastasis
• Laparoscopic Liver Resection
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Procedure:
• Liver resection
The investigators perform an anatomical liver resections or wedge resections depending on tumour's location and tumour's characteristics

Locations

Country	Name	City	State
Spain	Hospital Universitario "Virgen de la Arrixaca"	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Virgen de la Arrixaca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		1 year
Secondary	Surgical operative time	Duration of the surgical intervention	Intraoperative
Secondary	Blood losses	Blood loss in milliliter	Intraoperative
Secondary	Transfusion	Number of blood transfusions required during surgical operation	Intraoperative
Secondary	Hospital stay	Days between surgical operation and hospital discharge	Up to 3 months
Secondary	Time between surgery and adjuvant chemotherapy	Days between surgical operation and the beginning of adjuvant chemotherapy	Up to 3 months
Secondary	Mortality		90 days
Secondary	Morbidity		90 days