NCT03130920

Brief Summary

The aim of this study is to evaluate hepatoprotective effect from ischemia-reperfusion injury of remote ischemic preconditioning of the liver against local ischemic preconditioning of the liver during human liver resections.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 1, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

April 20, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2018

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

3 months

First QC Date

April 1, 2017

Last Update Submit

October 10, 2018

Conditions

Liver Metastases

Keywords

preconditioning, resection

Outcome Measures

Primary Outcomes (1)

  • Change in synthetic liver function

    We measured residual synthetic liver function and liver ischemic-reperfusion injury by value level of bilirubin, total proteins, albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), glutamic aminotransferase (ƴGT), cholinesterase, alkaline phosphatase (AP), coagulogram.

    Preoperatively, first, third and seventh postoperative day

Secondary Outcomes (2)

  • Flow through the hepatic artery and portal vein

    Before and after preconditioning

  • Liver histology evaluation

    Up to 10 days after operation

Study Arms (3)

Control

NO INTERVENTION

Remote ischemic preconditioning

ACTIVE COMPARATOR
Procedure: Preconditioning

Local ischemic preconditioning

ACTIVE COMPARATOR
Procedure: Preconditioning

Interventions

PreconditioningPROCEDURE

Local ischemic preconditioning (LIPC) is process during which a short period of ischemia is followed by a period of reperfusion prior to the prolonged ischemia which seems to render organs more tolerant to the IR(ischemic-reperfusion) injury. Remote ischemic preconditioning (RIPC) involves the protection of an organ from prolonged ischemia by brief periods of ischemia and reperfusion to a remote organ.

Local ischemic preconditioningRemote ischemic preconditioning

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with colorectal cancer liver metastasis all of which signed an informed consent

You may not qualify if:

  • having any other underlying liver disease, or preoperative increased liver transaminase, bilirubin
  • patients with chronic cardiac, pulmonary or renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Dubrava

Zagreb, 10000, Croatia

Location

Study Officials

  • Leonardo Patrlj

    Clinical Hospital Dubrava

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of hepatobilliary Department of surgery

Study Record Dates

First Submitted

April 1, 2017

First Posted

April 27, 2017

Study Start

April 20, 2017

Primary Completion

July 4, 2017

Study Completion

April 20, 2018

Last Updated

October 11, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

CR(1)