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

NCT ID: NCT04178759

Last Updated: 2019-11-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2022-04-01

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.

Conditions

Liver Regeneration; Liver Metastases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Control

Patients with benign liver disease, who undergo liver resection

Group Type: ACTIVE_COMPARATOR

Liver resection

Intervention Type: PROCEDURE

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

Experimental

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

Group Type: EXPERIMENTAL

Liver resection

Intervention Type: PROCEDURE

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

Interventions

Liver resection

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Pregnant women
• Liver resection is not performed

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vilnius University

OTHER

Sponsor Role: lead

Responsible Party

Kestutis Strupas

Chair of Department of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vilnius University Hospital Santaros Clinics

Vilnius, , Lithuania

Site Status: RECRUITING

Countries

Lithuania

Facility Contacts

Rokas Račkauskas, MD

Role: primary

info@santa.lt

+37060190691

Kęstutis Strupas, Prof.

Role: backup

info@santa.lt

Other Identifiers

2019/3-1112-605

Identifier Type: -

Identifier Source: org_study_id