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

Liver Metastases Clinical Trial

— VULSK-Hep  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04178759
• Other study ID #: 2019/3-1112-605
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: November 2019
• Source: Vilnius University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant women

• Liver resection is not performed

Related Conditions & MeSH terms

• Liver Metastases
• Liver Neoplasms
• Liver Regeneration
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Procedure:
• Liver resection
Laparoscopic or open approach liver resection where at least 1 segment is removed

Locations

Country	Name	City	State
Lithuania	Vilnius University Hospital Santaros Clinics	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
Vilnius University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of regenerated liver after liver resection	Difference of liver volume preoperatively and postoperatively, meassured by CT	30 days
Secondary	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
Secondary	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
Secondary	Evaluation of short term surgical outcomes	Complication rate will be assessed after 30 and 90 days post operatively	90 days