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Trial record 13 of 33 for:    Open Studies | Exclude Unknown | liver | NIDDK

Observational Study of Biomarker During Liver Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by University of Florida
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT02102971
First received: March 31, 2014
Last updated: May 10, 2016
Last verified: May 2016
  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 surgery

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   (Adult, Senior)
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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Jae-Sung Kim, PhD University of Florida
  More Information

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: May 10, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 27, 2016