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Observational Study of Biomarker During Liver Surgery

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ClinicalTrials.gov Identifier: NCT02102971
Recruitment Status : Recruiting
First Posted : April 3, 2014
Last Update Posted : March 19, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Liver Cancer Hepatobiliary Tract Adenomas and Carcinomas Procedure: Hepatocellular carcinoma

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.

Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Autophagy in Liver Injury: Changes in Autophagy Biomarkers During Liver Surgery
Study Start Date : October 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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.
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.
Other Names:
  • Liver resection
  • Liver transplantation surgery



Primary Outcome Measures :
  1. Biochemical analysis of sirtuin1 from liver tissues during liver surgery [ Time Frame: 30 minutes during liver surgery ]

Biospecimen Retention:   Samples With DNA
liver tissues during liver surgery


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Liver Disease Requring Liver Resection Surgery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102971


Contacts
Contact: Jae-Sung Kim, PhD 352-392-7461 jae.kim@surgery.ufl.edu

Locations
United States, Florida
UF Health Recruiting
Gainesville, Florida, United States, 32610
Contact: Jae-Sung Kim, PhD    352-392-7461    jae.kim@surgery.ufl.edu   
Sponsors and Collaborators
University of Florida
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Jae-Sung Kim, PhD University of Florida

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02102971     History of Changes
Other Study ID Numbers: IRB201400182 -N
R01DK079879 ( U.S. NIH Grant/Contract )
First Posted: April 3, 2014    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
liver
ischemia
reperfusion

Additional relevant MeSH terms:
Liver Neoplasms
Liver Diseases
Adenoma
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Extracts
Hematinics