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Impact of Chemotherapy and Regenerative Markers of Liver Regeneration After Liver Resection for Liver Metastases (VULSK-Hep)

Primary Purpose

Liver Regeneration, Liver Metastases

Status
Unknown status
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Liver resection
Sponsored by
Vilnius University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Regeneration focused on measuring Liver metastases, Liver regeneration, Markers

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant women
  • Liver resection is not performed

Sites / Locations

  • Vilnius University Hospital Santaros ClinicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Experimental

Arm Description

Patients with benign liver disease, who undergo liver resection

Patients with liver metastases and received chemotherapy, who undergo liver resection

Outcomes

Primary Outcome Measures

Volume of regenerated liver after liver resection
Difference of liver volume preoperatively and postoperatively, meassured by CT

Secondary Outcome Measures

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;
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
Evaluation of short term surgical outcomes
Complication rate will be assessed after 30 and 90 days post operatively

Full Information

First Posted
November 22, 2019
Last Updated
November 25, 2019
Sponsor
Vilnius University
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1. Study Identification

Unique Protocol Identification Number
NCT04178759
Brief Title
Impact of Chemotherapy and Regenerative Markers of Liver Regeneration After Liver Resection for Liver Metastases
Acronym
VULSK-Hep
Official Title
Impact of Chemotherapy and Regenerative Markers on Liver Regeneration After Liver Resection for Liver Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
April 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vilnius University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Regeneration, Liver Metastases
Keywords
Liver metastases, Liver regeneration, Markers

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients with benign liver disease, who undergo liver resection
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Patients with liver metastases and received chemotherapy, who undergo liver resection
Intervention Type
Procedure
Intervention Name(s)
Liver resection
Intervention Description
Laparoscopic or open approach liver resection where at least 1 segment is removed
Primary Outcome Measure Information:
Title
Volume of regenerated liver after liver resection
Description
Difference of liver volume preoperatively and postoperatively, meassured by CT
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Evaluation of liver fibrosis
Description
The dynamic of liver fibrosis will be measured by ultrasound elastography pre-op and post-op day 1, 7 and 30;
Time Frame
30 days
Title
Evaluation of liver markers responsible for liver regeneration
Description
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
Time Frame
30 days
Title
Evaluation of short term surgical outcomes
Description
Complication rate will be assessed after 30 and 90 days post operatively
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Patients with liver lesions, who are eligible for liver resection Exclusion Criteria: Pregnant women Liver resection is not performed
Facility Information:
Facility Name
Vilnius University Hospital Santaros Clinics
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rokas Račkauskas, MD
Phone
+37060190691
Email
info@santa.lt
First Name & Middle Initial & Last Name & Degree
Kęstutis Strupas, Prof.
Email
info@santa.lt

12. IPD Sharing Statement

Learn more about this trial

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

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