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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04178759
Acronym
VULSK-Hep
Enrollment
100
Registered
2019-11-26
Start date
2019-09-01
Completion date
2022-04-01
Last updated
2019-11-26

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

Conditions

Liver Metastases, Liver Regeneration

Keywords

Liver metastases, Liver regeneration, Markers

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.

Interventions

PROCEDURELiver resection

Laparoscopic or open approach liver resection where at least 1 segment is removed

Sponsors

Vilnius University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Pregnant women * Liver resection is not performed

Design outcomes

Primary

MeasureTime frameDescription
Volume of regenerated liver after liver resection30 daysDifference of liver volume preoperatively and postoperatively, meassured by CT

Secondary

MeasureTime frameDescription
Evaluation of liver fibrosis30 daysThe 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 regeneration30 daysExpression 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 outcomes90 daysComplication rate will be assessed after 30 and 90 days post operatively

Countries

Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026