Observational Study of Biomarker During Liver Surgery

Terminated

• Conditions: Liver Cancer; Hepatobiliary Tract Adenomas and Carcinomas
• Interventions: Procedure: Hepatocellular carcinoma

• Registration Number: NCT02102971
• Lead Sponsor: University of Florida

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-03-31
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-03
• Study Start: 2014-10
• Primary Completion: 2019-06-06
• Study Completion: 2019-06-06
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• liver resection > 2 segments,
• plate count > 100 x 109/L, and
• prothrombin activity >60%.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hepatocellular carcinoma	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.

Primary Outcome Measures

Name	Time	Method
Biochemical analysis of sirtuin1 from liver tissues during liver surgery	30 minutes during liver surgery

Trial Locations

Locations (1)

UF Health; 🇺🇸 Gainesville, Florida, United States