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NCT02102971 Clinical Trial

Observational Study of Biomarker During Liver Surgery

Liver Cancer Clinical Trial

Official title:
Autophagy in Liver Injury: Changes in Autophagy Biomarkers During Liver Surgery

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02102971
Other study ID # IRB201400182 -N
Secondary ID R01DK079879
Status Terminated
Phase
First received
Last updated
Start date October 2014
Est. completion date June 6, 2019

Study information
Verified date September 2019
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators would like to study whether Sirtuin 1 (SIRT1) plays a cytoprotective role in liver ischemia/reperfusion, and ultimately to develop therapeutic strategies to improve hepatic function of patients with liver diseases.

Description:

If asked to participate in this research study, it is because a liver resection/liver transplantation surgery has been scheduled. During the procedure a small section will be collected for additional testing of Sirtuin 1. In addition, information concerning the liver disease, laboratory and pathology results after surgery will be collected by the investigators.

Recruitment information / eligibility
Status Terminated
Enrollment 41
Est. completion date June 6, 2019
Est. primary completion date June 6, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- liver resection > 2 segments,

- plate count > 100 x 109/L, and

- prothrombin activity >60%.

Exclusion Criteria:

- liver cirrhosis,

- portal hypertension,

- steatohepatitis or severe steatosis,

- patients receiving additional ablation therapies,

- laparoscopic resection, and

- simultaneous extrahepatic procedures such as colorectal resection or pancreatoduodenectomy

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Hepatocellular carcinoma
Participants undergoing a liver resection/liver transplantation surgery. During the liver surgery a small piece of tissue will be removed to undergo additional laboratory testing.

Locations
Country Name City State
United States UF Health Gainesville Florida

Sponsors (2)
Lead Sponsor Collaborator
University of Florida National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Biochemical analysis of sirtuin1 from liver tissues during liver surgery 30 minutes during liver surgery
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