Hepatoprotective Effect of Remote vs Local Preconditioning of Liver

Not Applicable

Completed

• Conditions: Liver Metastases
• Interventions: Procedure: Preconditioning

• Registration Number: NCT03130920
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2017-04-01
• Study Start: 2017-04-20
• Study First Submitted QC: 2017-04-23
• Study First Posted: 2017-04-27
• Primary Completion: 2017-07-04
• Study Completion: 2018-04-20
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote ischemic preconditioning	Preconditioning	-
Local ischemic preconditioning	Preconditioning	-

Primary Outcome Measures

Name	Time	Method
Change in synthetic liver function	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

Name	Time	Method
Flow through the hepatic artery and portal vein	Before and after preconditioning	During operation we preformed Doppler ultrasonography of hepatic artery and portal vein.
Liver histology evaluation	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.

Trial Locations

Locations (1)

University Hospital Dubrava; 🇭🇷 Zagreb, Croatia