Impact of Chemotherapy and Regenerative Markers of Liver Regeneration After Liver Resection for Liver Metastases

Study Overview
=================
Brief Summary
-----------------
Liver is special organ, which can regenerate. On that ability there are many treatment modalities, where liver resection is performed, especially in cancer patients with liver metastases. Liver regeneration provides an opportunity for these patients to undergo multiple treatment regimes and liver resections to achieve curability. There are many factors that impair liver regeneration. One of these factors is chemotherapy. Literature data on impact of chemotherapy to liver regeneration is ambiguous. Therefore we aim to research impact of chemotherapy to liver regeneration.

Detailed Description
-----------------
Liver is the largest parenchymal organ responsible for over 500 different functions in human body, which are detoxification of various toxins, drugs, synthesis of proteins and enzymes, coagulation factors. Liver is special organ, which can regenerate. If 75% of liver is removed it can regenerate to its normal size. Liver volume is very important to liver function, if there is volume insufficiency it could lead to liver failure in addition to other factors that impair liver regeneration. On that regenerative ability there are many treatment modalities, when liver resection is performed, especially in cancer patients with liver metastases. Modern treatment modalities are based on combination of different treatments, surgical and chemotherapeutic. On the other hand, side effects of chemotherapy should not be discarded, which can increase patient morbidity and mortality. Thus, liver regeneration provides an opportunity for these patients to undergo multiple treatment regimes and liver resections to achieve curability. Literature data on impact of chemotherapy to liver regeneration is ambiguous. Therefore we aim to research impact of chemotherapy to liver regeneration.

Official Title
-----------------
Impact of Chemotherapy and Regenerative Markers on Liver Regeneration After Liver Resection for Liver Metastases

Conditions
-----------------
Liver Regeneration, Liver Metastases

Intervention / Treatment
-----------------
* Procedure: Liver resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Patients with liver lesions, who are eligible for liver resection Exclusion Criteria: Pregnant women Liver resection is not performed

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Patients with benign liver disease, who undergo liver resection | Procedure: Liver resection<br>* Laparoscopic or open approach liver resection where at least 1 segment is removed<br>|
| Experimental: Experimental<br>Patients with liver metastases and received chemotherapy, who undergo liver resection | Procedure: Liver resection<br>* Laparoscopic or open approach liver resection where at least 1 segment is removed<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of regenerated liver after liver resection | Difference of liver volume preoperatively and postoperatively, meassured by CT | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of liver fibrosis | The dynamic of liver fibrosis will be measured by ultrasound elastography pre-op and post-op day 1, 7 and 30; | 30 days | 
| Evaluation of liver markers responsible for liver regeneration | Expression of liver regeneration markers - hepatocyte growth factor and tumor growth factor beta1 - will be measured before and post-op day 1,3 and 7 in serum and also in liver tissue with immunohistochemistry | 30 days | 
| Evaluation of short term surgical outcomes | Complication rate will be assessed after 30 and 90 days post operatively | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver metastases, Liver regeneration, Markers