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
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 |
Verified date | October 2018 |
Source | University Hospital Dubrava |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Croatia | University Hospital Dubrava | Zagreb |
Lead Sponsor | Collaborator |
---|---|
University Hospital Dubrava |
Croatia,
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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