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

Primary Purpose

Colorectal Liver Metastasis, Laparoscopic Liver Resection

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Liver resection
Sponsored by
Hospital Universitario Virgen de la Arrixaca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Liver Metastasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Universitario "Virgen de la Arrixaca"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic group

Open group

Arm Description

Liver resection performed by laparoscopic approach

Liver resection performed by open approach

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Surgical operative time
Duration of the surgical intervention
Blood losses
Blood loss in milliliter
Transfusion
Number of blood transfusions required during surgical operation
Hospital stay
Days between surgical operation and hospital discharge
Time between surgery and adjuvant chemotherapy
Days between surgical operation and the beginning of adjuvant chemotherapy
Mortality
Morbidity

Full Information

First Posted
March 14, 2016
Last Updated
December 19, 2017
Sponsor
Hospital Universitario Virgen de la Arrixaca
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1. Study Identification

Unique Protocol Identification Number
NCT02727179
Brief Title
Open vs Laparoscopic Liver Surgery for Colorectal Liver Metastases
Acronym
LapOpHuva
Official Title
Prospective and Randomized Study Comparing Open vs Laparoscopic Liver Surgery for Colorectal Liver Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Virgen de la Arrixaca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Liver Metastasis, Laparoscopic Liver Resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic group
Arm Type
Experimental
Arm Description
Liver resection performed by laparoscopic approach
Arm Title
Open group
Arm Type
Active Comparator
Arm Description
Liver resection performed by open approach
Intervention Type
Procedure
Intervention Name(s)
Liver resection
Intervention Description
The investigators perform an anatomical liver resections or wedge resections depending on tumour's location and tumour's characteristics
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Surgical operative time
Description
Duration of the surgical intervention
Time Frame
Intraoperative
Title
Blood losses
Description
Blood loss in milliliter
Time Frame
Intraoperative
Title
Transfusion
Description
Number of blood transfusions required during surgical operation
Time Frame
Intraoperative
Title
Hospital stay
Description
Days between surgical operation and hospital discharge
Time Frame
Up to 3 months
Title
Time between surgery and adjuvant chemotherapy
Description
Days between surgical operation and the beginning of adjuvant chemotherapy
Time Frame
Up to 3 months
Title
Mortality
Time Frame
90 days
Title
Morbidity
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo Robles Campos, MD; PHD
Organizational Affiliation
Hospital Universitario Virgen de la Arrixaca
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitario "Virgen de la Arrixaca"
City
Murcia
ZIP/Postal Code
30120
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30701365
Citation
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.
Results Reference
derived

Learn more about this trial

Open vs Laparoscopic Liver Surgery for Colorectal Liver Metastases

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