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Open vs Laparoscopic Liver Surgery for Colorectal Liver Metastases

NCT ID: NCT02727179

Last Updated: 2017-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2017-03-31

Brief Summary

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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

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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

Conditions

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Colorectal Liver Metastasis Laparoscopic Liver Resection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laparoscopic group

Liver resection performed by laparoscopic approach

Group Type EXPERIMENTAL

Liver resection

Intervention Type PROCEDURE

The investigators perform an anatomical liver resections or wedge resections depending on tumour's location and tumour's characteristics

Open group

Liver resection performed by open approach

Group Type ACTIVE_COMPARATOR

Liver resection

Intervention Type PROCEDURE

The investigators perform an anatomical liver resections or wedge resections depending on tumour's location and tumour's characteristics

Interventions

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Liver resection

The investigators perform an anatomical liver resections or wedge resections depending on tumour's location and tumour's characteristics

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario Virgen de la Arrixaca

OTHER

Sponsor Role lead

Responsible Party

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Ricardo Robles Campos

MD, PHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ricardo Robles Campos, MD; PHD

Role: STUDY_CHAIR

Hospital Universitario Virgen de la Arrixaca

Locations

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Hospital Universitario "Virgen de la Arrixaca"

Murcia, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 30701365 (View on PubMed)

Other Identifiers

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HUVA-0515

Identifier Type: -

Identifier Source: org_study_id