Consequences of liver surgery for liver function and cell injury

Consequences of liver surgery for liver function and cell injury - Liver surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON30540

Enrollment

Registered

2007-05-14

Start date

2007-09-28

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver metastases

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with resectable liver tumors (mostly colorectal cancer liver metastases) who undergo a liver resection at the University Hospital Maastricht. Patients should be older than 18 years and younger than 75 years.

Exclusion criteria

Exclusion criteria: Parenchymal liver disease, inflammatory liver disease, inborn errors of metabolism (liver enzyme deficiencies), steroid hormone medication, n-acetyl cystein medication

Design outcomes

Primary

Measure	Time frame
As the primary endpoint, we will look at plasma levels of novel markers of liver damage, such as ophthalmic acid and Liver - Fatty Acid Binding Protein (L-FABP), as well as more traditional markers such as ASAT, ALAT. We will compare the alanin aminotransferase (ALAT) and aspartate aminotransferase (ASAT) plasma levels between the three groups. ASAT and ALAT are commonly used and accepted as parameters for liver cell injury and will be used as the gold standard in this study. However ASAT and ALAT are crude estimates of liver cell injury because they are gradually and slowly released from injured cells and remain in the circulation for a long period. Esaki (5) et al concluded that there was no clinically relevant difference in the bilirubin ratio and ASAT/ ALAT levels on the second post operative day between two groups of patients that underwent a period of 15* or 30* minutes liver ischemia. In this study the aim is to investigate the effects of 15* liver ischemia versus 30* liver ischemia using more sophisticated markers of liver injury and liver function such as L-FABP and Ophthalmic acid. L-FABP plasma levels are currently arising as more sensitive and specific plasma markers for hepatic injury. L-FABP*s are small and cystolic proteins which after leakage from injured cells have a short plasma half-life. The L-FABP plasma level is a good liver injury marker because it possesses liver tissue-specificity and its molecular weight is low by which it can be released from injured liver cells in an early stage and in significant amounts. During liver surgery (resection, transplantation) the liver is exposed to oxidative stress during the phase of temporary clamping of the portal vein and hepatic artery. Ischemia is typically characterized by ATP depletion and necrotic cell death. Upon reperfusion a multifactorial process leading to apoptotic cell death is initiated that further aggravates cell injury already initiated by plain ischemia. An impo	—

Measure

Time frame

As the primary endpoint, we will look at plasma levels of novel markers of liver damage, such as ophthalmic acid and Liver - Fatty Acid Binding Protein (L-FABP), as well as more traditional markers such as ASAT, ALAT. We will compare the alanin aminotransferase (ALAT) and aspartate aminotransferase (ASAT) plasma levels between the three groups. ASAT and ALAT are commonly used and accepted as parameters for liver cell injury and will be used as the gold standard in this study. However ASAT and ALAT are crude estimates of liver cell injury because they are gradually and slowly released from injured cells and remain in the circulation for a long period. Esaki (5) et al concluded that there was no clinically relevant difference in the bilirubin ratio and ASAT/ ALAT levels on the second post operative day between two groups of patients that underwent a period of 15* or 30* minutes liver ischemia. In this study the aim is to investigate the effects of 15* liver ischemia versus 30* liver ischemia using more sophisticated markers of liver injury and liver function such as L-FABP and Ophthalmic acid. L-FABP plasma levels are currently arising as more sensitive and specific plasma markers for hepatic injury. L-FABP*s are small and cystolic proteins which after leakage from injured cells have a short plasma half-life. The L-FABP plasma level is a good liver injury marker because it possesses liver tissue-specificity and its molecular weight is low by which it can be released from injured liver cells in an early stage and in significant amounts. During liver surgery (resection, transplantation) the liver is exposed to oxidative stress during the phase of temporary clamping of the portal vein and hepatic artery. Ischemia is typically characterized by ATP depletion and necrotic cell death. Upon reperfusion a multifactorial process leading to apoptotic cell death is initiated that further aggravates cell injury already initiated by plain ischemia. An impo

—

Secondary

Measure	Time frame
Concentrations of different inflammatory and intestinal damage markers will be measured in blood. Inflammatory markers - Soluble TNF-receptor (n75/ n55) - IL-6 - IL-8 - Interferon-γ - MPO - IL-10 Intestinal damage markers: - Intestinal Fatty Acid Binding Protein (I-FABP) - Ileal Lipid Binding Protein (I-LBP)	—

Countries

Netherlands

Outcome results