Hepatoprotective Effect of Remote vs Local Preconditioning of Liver

NCT ID: NCT03130920

Last Updated: 2018-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-20

Study Completion Date

2018-04-20

Brief Summary

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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.

Detailed Description

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In this randomized control study, a total of 60 patients were randomized into 3 groups: remote ischemic precondition group - RIPC (3 intervals of 5 minute right upper limb ischemia with 3 intervals of 5 minute reperfusion), local ischemic precondition group - LIPC (15 minutes of inflow liver occlusion followed by 10 minutes of reperfusion before liver transection), control group - CG (group without ischemic preconditioning before liver transection). Patients were also stratified according to the extent of the hepatectomy. Hepatoprotective effect was evaluated by comparing serum transaminase levels, bilirubin levels, albumin, and protein levels, coagulograms and pathohistological exams. We also measured flow rate by Doppler ultrasound of hepatic artery and portal vein before and after preconditioning.

Conditions

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Liver Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Remote ischemic preconditioning

Group Type ACTIVE_COMPARATOR

Preconditioning

Intervention Type PROCEDURE

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 preconditioning

Group Type ACTIVE_COMPARATOR

Preconditioning

Intervention Type PROCEDURE

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.

Interventions

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Preconditioning

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* having any other underlying liver disease, or preoperative increased liver transaminase, bilirubin
* patients with chronic cardiac, pulmonary or renal disease
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Dubrava

OTHER

Sponsor Role lead

Responsible Party

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Mislav Rakić, MD

Head of hepatobilliary Department of surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leonardo Patrlj

Role: STUDY_CHAIR

Clinical Hospital Dubrava

Locations

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University Hospital Dubrava

Zagreb, , Croatia

Site Status

Countries

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Croatia

Other Identifiers

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UHDubrava

Identifier Type: -

Identifier Source: org_study_id

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