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Hepatoprotective Effect of Remote vs Local Preconditioning of Liver

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ClinicalTrials.gov Identifier: NCT03130920
Recruitment Status : Completed
First Posted : April 27, 2017
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Mislav Rakić, MD, University Hospital Dubrava

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.

Condition or disease Intervention/treatment Phase
Liver Metastases Procedure: Preconditioning Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Hepatoprotective Effect From Ischemia-reperfusion Injury of Remote Ischemic Preconditioning of the Liver vs. Local Ischemic Preconditioning of the Liver During Human Liver Resections
Actual Study Start Date : April 20, 2017
Actual Primary Completion Date : July 4, 2017
Actual Study Completion Date : April 20, 2018

Arm Intervention/treatment
No Intervention: Control
Active Comparator: Remote ischemic preconditioning Procedure: 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.


Active Comparator: Local ischemic preconditioning Procedure: 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.





Primary Outcome Measures :
  1. Change in synthetic liver function [ Time Frame: Preoperatively, first, third and seventh postoperative day ]
    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.


Secondary Outcome Measures :
  1. Flow through the hepatic artery and portal vein [ Time Frame: Before and after preconditioning ]
    During operation we preformed Doppler ultrasonography of hepatic artery and portal vein.

  2. Liver histology evaluation [ Time Frame: Up to 10 days after operation ]
    Liver paraffin-embedded, standard haematoxylin-eosin stained sections were analysed postoperatively to evaluate the ischemic reperfusion injury . According to Rodriguez et al. four elements of the liver histology were analysed: steatosis (micro vesicular and macro vesicular) in 4 grades, degree of sinusoidal congestion and dilatation in 3 grades, leukocyte infiltration in 3 grades and necrosis (focal, confluent, or zonal) in 3 grades.26 Each biopsy was evaluated by a single pathologist blinded to the treatment allocation.



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130920


Locations
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Croatia
University Hospital Dubrava
Zagreb, Croatia, 10000
Sponsors and Collaborators
University Hospital Dubrava
Investigators
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Study Chair: Leonardo Patrlj Clinical Hospital Dubrava

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Responsible Party: Mislav Rakić, MD, Head of hepatobilliary Department of surgery, University Hospital Dubrava
ClinicalTrials.gov Identifier: NCT03130920     History of Changes
Other Study ID Numbers: UHDubrava
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mislav Rakić, MD, University Hospital Dubrava:
preconditioning, resection