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

Not Applicable

• Conditions: Liver Regeneration; Liver Metastases
• Interventions: Procedure: Liver resection

• Registration Number: NCT04178759
• Lead Sponsor: Vilnius University

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.

Study Timeline

• Study Start: 2019-09-01
• Status Verified: 2019-11
• Study First Submitted: 2019-11-22
• Study First Submitted QC: 2019-11-25
• Last Update Submitted: 2019-11-25
• Study First Posted: 2019-11-26
• Last Update Posted: 2019-11-26
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with liver lesions, who are eligible for liver resection

Exclusion Criteria

• Pregnant women
• Liver resection is not performed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Liver resection	Patients with liver metastases and received chemotherapy, who undergo liver resection
Control	Liver resection	Patients with benign liver disease, who undergo liver resection

Primary Outcome Measures

Name	Time	Method
Volume of regenerated liver after liver resection	30 days	Difference of liver volume preoperatively and postoperatively, meassured by CT

Secondary Outcome Measures

Name	Time	Method
Evaluation of liver fibrosis	30 days	The dynamic of liver fibrosis will be measured by ultrasound elastography pre-op and post-op day 1, 7 and 30;
Evaluation of liver markers responsible for liver regeneration	30 days	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
Evaluation of short term surgical outcomes	90 days	Complication rate will be assessed after 30 and 90 days post operatively

Trial Locations

Locations (1)

Vilnius University Hospital Santaros Clinics; 🇱🇹 Vilnius, Lithuania