Hepatoprotective Effect of Remote vs Local Preconditioning of Liver

Liver Metastases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03130920
• Other study ID #: UHDubrava
• Status: Completed
• Phase: N/A
• Start date: April 20, 2017
• Est. completion date: April 20, 2018

Study information

• Verified date: October 2018
• Source: University Hospital Dubrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 20, 2018
• Est. primary completion date: July 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Metastases

Intervention

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.

Locations

Country	Name	City	State
Croatia	University Hospital Dubrava	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Dubrava

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (?GT), cholinesterase, alkaline phosphatase (AP), coagulogram.	Preoperatively, first, third and seventh postoperative day
Secondary	Flow through the hepatic artery and portal vein	During operation we preformed Doppler ultrasonography of hepatic artery and portal vein.	Before and after preconditioning
Secondary	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.	Up to 10 days after operation