The Inflammatory Response to Stress and Angiogenesis in Liver Resection

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03131778
• Other study ID #: 2006/048
• Status: Completed
• Phase: N/A
• First received: April 20, 2017
• Last updated: April 27, 2017
• Start date: April 1, 2010
• Est. completion date: June 30, 2011

Study information

• Verified date: April 2017
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2011
• Est. primary completion date: June 30, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 18-80 years old

2. Patients with colorectal liver metastases

3. Colorectal liver metastases =10 cm in size -

Exclusion Criteria:

1. Patients not fit for laparoscopic surgery due to comorbidities

2. Patients with tumors close or infiltrating the major vessels -

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Liver Cancer
• Liver Metastases
• Liver Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Procedure:
• Liver resection
liver resections for colorectal liver metastases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

References & Publications (3)

Buunen M, Gholghesaei M, Veldkamp R, Meijer DW, Bonjer HJ, Bouvy ND. Stress response to laparoscopic surgery: a review. Surg Endosc. 2004 Jul;18(7):1022-8. Epub 2004 May 12. Review. — View Citation

Fretland AA, Sokolov A, Postriganova N, Kazaryan AM, Pischke SE, Nilsson PH, Rognes IN, Bjornbeth BA, Fagerland MW, Mollnes TE, Edwin B. Inflammatory Response After Laparoscopic Versus Open Resection of Colorectal Liver Metastases: Data From the Oslo-CoMet Trial. Medicine (Baltimore). 2015 Oct;94(42):e1786. doi: 10.1097/MD.0000000000001786. Erratum in: Medicine (Baltimore). 2016 Mar;95(10):e367e. — View Citation

Ueda K, Turner P, Gagner M. Stress response to laparoscopic liver resection. HPB (Oxford). 2004;6(4):247-52. doi: 10.1080/13651820410023987. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in inflammatory response	Differences in POD 1 levels of IL6 and IL8	Preoperative and postoperative day 1
Secondary	Differences in tumor stimulating factors	Differences in levels of VEGF, HIF-1a, MMP-9 and COX2 in both humoral and normal liver tissue	One week after surgery
Secondary	Overall Survival	From surgery to date of death or last follow up. Data will be reported in months	1-3-5 years
Secondary	Recurrence free survival	From surgery to recurrence either in the liver or elsewhere. Data will be reported in months	1-3-5 years