Observational Study of Biomarker During Liver Surgery

NCT ID: NCT02102971

Last Updated: 2019-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2019-06-06

Brief Summary

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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

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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.

Conditions

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Liver Cancer Hepatobiliary Tract Adenomas and Carcinomas

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Hepatocellular carcinoma

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Liver resection Liver transplantation surgery

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jae-Sung Kim, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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UF Health

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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R01DK079879

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB201400182 -N

Identifier Type: -

Identifier Source: org_study_id

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