Observational Study of Biomarker During Liver Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Florida
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT02102971
First received: March 31, 2014
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

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 Intervention
Liver Cancer
Hepatobiliary Tract Adenomas and Carcinomas
Procedure: Hepatocellular carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Autophagy in Liver Injury: Changes in Autophagy Biomarkers During Liver Surgery

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Biochemical analysis of sirtuin1 from liver tissues during liver surgery [ Time Frame: 30 minutes during liver surgery ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

liver tissues during liver surgery


Estimated Enrollment: 70
Study Start Date: October 2014
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 sugery

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Jae-Sung Kim, PhD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02102971     History of Changes
Other Study ID Numbers: 201400182, R01DK079879
Study First Received: March 31, 2014
Last Updated: October 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
liver
ischemia
reperfusion

Additional relevant MeSH terms:
Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Neoplasms
Neoplasms by Site
Liver Extracts
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014