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OpenTrials
Completed

NCT Number: NCT03131778

The Inflammatory Response to Stress and Angiogenesis in Liver Resection

Patients with resectable liver metastases of colorectal origin will be assigned to laparoscopic liver resection or conventional open liver surgery.

Blood samples will be drawn preoperatively and 24 hours after resection. Determination of Interleukin-6 (IL-6) and IL-8 will be done to assess the stress response between open and laparoscopic liver resection (Elisa test).

The Messenger Ribonucleic Acid (mRNA) of inflammation related factors (cyclooxygenase-2 (COX-2) and Matrix metalloproteinase (MMP-9)), angiogenesis related factor (vascular endothelial growth factor (VEGF) and hypoxia induced factor-1 (HIF-1)) in tumor tissue and normal liver parenchyma will be detected by real-time real time-Polymerase Chain Reaction (RT-PCR).

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Key information

Conditions

Liver Cancer Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Metastases Liver Neoplasms Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

According to the null hypothesis, no difference in the IL6 postoperative value, between the two groups would be expected. To calculate sample size, a IL6 postoperative value of 100±40 pg/mL in the laparoscopic group and 60±40 mL/m pg/mL in the open group was hypothesized. Considering a two-sided α=0.05 and β=0.1, the minimal sample size required to achieve statistical significance was 17 subjects in both groups in a 1:1 randomization. Laparoscopic group was increased by 20% of patients considering a conversion rate of 20% accordingly. Randomization will be performed using computer-generated random numbers the day before operation and stopped when 20 patients per group will be reached.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-80 years old
  • Patients with colorectal liver metastases
  • Colorectal liver metastases ≤10 cm in size -

Exclusion criteria

  • Patients not fit for laparoscopic surgery due to comorbidities
  • Patients with tumors close or infiltrating the major vessels -

Treatment and study plan

liver resection

Procedure

liver resections for colorectal liver metastases

Primary outcomes

  1. Differences in inflammatory response

    Time frame: Preoperative and postoperative day 1

    Differences in POD 1 levels of IL6 and IL8

Secondary outcomes

  1. Differences in tumor stimulating factors

    Time frame: One week after surgery

    Differences in levels of VEGF, HIF-1α, MMP-9 and COX2 in both humoral and normal liver tissue

  2. Overall Survival

    Time frame: 1-3-5 years

    From surgery to date of death or last follow up. Data will be reported in months

  3. Recurrence free survival

    Time frame: 1-3-5 years

    From surgery to recurrence either in the liver or elsewhere. Data will be reported in months

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

The Inflammatory Response to Stress and Angiogenesis in Open Versus Laparoscopic Liver Resection for Colorectal Liver Metastases

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 27, 2017
Registry last updated
May 1, 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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