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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Liver Metastasis; Laparoscopic Liver Resection
• Intervention / Treatment: Procedure: Liver resection

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30120
    • Hospital Universitario "Virgen de la Arrixaca"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laparoscopic group; Liver resection performed by laparoscopic approach	Procedure: Liver resection; The investigators perform an anatomical liver resections or wedge resections depending on tumour's location and tumour's characteristics
Active Comparator: Open group; Liver resection performed by open approach	Procedure: Liver resection; The investigators perform an anatomical liver resections or wedge resections depending on tumour's location and tumour's characteristics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Universitario Virgen de la Arrixaca
• Investigators: Study Chair: Ricardo Robles Campos, MD; PHD, Hospital Universitario Virgen de La Arrixaca

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2005
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: March 14, 2016
• First Submitted That Met QC Criteria: March 29, 2016
• First Posted (Estimate): April 4, 2016

Study Record Updates

• Last Update Posted (Actual): December 20, 2017
• Last Update Submitted That Met QC Criteria: December 19, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Neoplastic Processes; Neoplasm Metastasis; Liver Neoplasms
• Other Study ID Numbers: HUVA-0515

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No