Open vs Laparoscopic Liver Surgery for Colorectal Liver Metastases
LapOpHuva
Prospective and Randomized Study Comparing Open vs Laparoscopic Liver Surgery for Colorectal Liver Metastases
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 14, 2016
CompletedFirst Posted
Study publicly available on registry
April 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedDecember 20, 2017
December 1, 2017
12.1 years
March 14, 2016
December 19, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival
1 year
Secondary Outcomes (7)
Surgical operative time
Intraoperative
Blood losses
Intraoperative
Transfusion
Intraoperative
Hospital stay
Up to 3 months
Time between surgery and adjuvant chemotherapy
Up to 3 months
- +2 more secondary outcomes
Study Arms (2)
Laparoscopic group
EXPERIMENTALLiver resection performed by laparoscopic approach
Open group
ACTIVE COMPARATORLiver resection performed by open approach
Interventions
The investigators perform an anatomical liver resections or wedge resections depending on tumour's location and tumour's characteristics
Eligibility Criteria
You may qualify if:
- Patients with colorectal liver metastases;
- Patients suitable for surgical treatment;
- Patients eligible for laparoscopy approach.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario "Virgen de la Arrixaca"
Murcia, 30120, Spain
Related Publications (1)
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.
PMID: 30701365DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ricardo Robles Campos, MD; PHD
Hospital Universitario Virgen de la Arrixaca
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PHD
Study Record Dates
First Submitted
March 14, 2016
First Posted
April 4, 2016
Study Start
February 1, 2005
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
December 20, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share