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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03130920
Other study ID # UHDubrava
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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