Hepatoprotective Effect of Remote vs Local Preconditioning of Liver
Primary Purpose
Liver Metastases
Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Preconditioning
Sponsored by
About this trial
This is an interventional treatment trial for Liver Metastases focused on measuring preconditioning, resection
Eligibility 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
Sites / Locations
- University Hospital Dubrava
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Control
Remote ischemic preconditioning
Local ischemic preconditioning
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Flow through the hepatic artery and portal vein
During operation we preformed Doppler ultrasonography of hepatic artery and portal vein.
Liver histology evaluation
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.
Full Information
NCT ID
NCT03130920
First Posted
April 1, 2017
Last Updated
October 10, 2018
Sponsor
University Hospital Dubrava
1. Study Identification
Unique Protocol Identification Number
NCT03130920
Brief Title
Hepatoprotective Effect of Remote vs Local Preconditioning of Liver
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
July 4, 2017 (Actual)
Study Completion Date
April 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Dubrava
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Metastases
Keywords
preconditioning, resection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Remote ischemic preconditioning
Arm Type
Active Comparator
Arm Title
Local ischemic preconditioning
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Preconditioning
Intervention Description
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 Measure Information:
Title
Change in synthetic liver function
Description
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.
Time Frame
Preoperatively, first, third and seventh postoperative day
Secondary Outcome Measure Information:
Title
Flow through the hepatic artery and portal vein
Description
During operation we preformed Doppler ultrasonography of hepatic artery and portal vein.
Time Frame
Before and after preconditioning
Title
Liver histology evaluation
Description
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.
Time Frame
Up to 10 days after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonardo Patrlj
Organizational Affiliation
Clinical Hospital Dubrava
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Dubrava
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
12. IPD Sharing Statement
Plan to Share IPD
No
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Hepatoprotective Effect of Remote vs Local Preconditioning of Liver
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