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OpenTrials
Completed

NCT Number: NCT02727179

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario "Virgen de la Arrixaca"

Murcia, 30120, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liver resection

Procedure

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

Primary outcomes

  1. Overall survival

    Time frame: 1 year

Secondary outcomes

  1. Surgical operative time

    Time frame: Intraoperative

    Duration of the surgical intervention

  2. Blood losses

    Time frame: Intraoperative

    Blood loss in milliliter

  3. Transfusion

    Time frame: Intraoperative

    Number of blood transfusions required during surgical operation

  4. Hospital stay

    Time frame: Up to 3 months

    Days between surgical operation and hospital discharge

  5. Time between surgery and adjuvant chemotherapy

    Time frame: Up to 3 months

    Days between surgical operation and the beginning of adjuvant chemotherapy

  6. Mortality

    Time frame: 90 days

  7. Morbidity

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

Hospital Universitario Virgen de la Arrixaca

Other

Registry information

Official study title

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

Acronym: LapOpHuva

Important dates

Study start
2005
Primary completion
2017
Study completion
2017
First posted
Apr 4, 2016
Registry last updated
Dec 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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