NCT04178759

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

2.6 years

First QC Date

November 22, 2019

Last Update Submit

November 25, 2019

Conditions

Liver RegenerationLiver Metastases

Keywords

Liver metastasesLiver regenerationMarkers

Outcome Measures

Primary Outcomes (1)

  • Volume of regenerated liver after liver resection

    Difference of liver volume preoperatively and postoperatively, meassured by CT

    30 days

Secondary Outcomes (3)

  • Evaluation of liver fibrosis

    30 days

  • Evaluation of liver markers responsible for liver regeneration

    30 days

  • Evaluation of short term surgical outcomes

    90 days

Study Arms (2)

Control

ACTIVE COMPARATOR

Patients with benign liver disease, who undergo liver resection

Procedure: Liver resection

Experimental

EXPERIMENTAL

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

Procedure: Liver resection

Interventions

Liver resectionPROCEDURE

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

ControlExperimental

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnant women
  • Liver resection is not performed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vilnius University Hospital Santaros Clinics

Vilnius, LT-08661, Lithuania

RECRUITING

MeSH Terms

Interventions

Hepatectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of Department of Surgery

Study Record Dates

First Submitted

November 22, 2019

First Posted

November 26, 2019

Study Start

September 1, 2019

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

November 26, 2019

Record last verified: 2019-11

Locations

LI(1)