NCT02102971

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

4.7 years

First QC Date

March 31, 2014

Last Update Submit

September 24, 2019

Conditions

Liver CancerHepatobiliary Tract Adenomas and Carcinomas

Keywords

liverischemiareperfusion

Outcome Measures

Primary Outcomes (1)

  • Biochemical analysis of sirtuin1 from liver tissues during liver surgery

    30 minutes during liver surgery

Study Arms (1)

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

Interventions

Hepatocellular carcinomaPROCEDURE

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.

Also known as: Liver resection, Liver transplantation surgery
Hepatocellular carcinoma

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Liver Disease Requring Liver Resection Surgery

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF Health

Gainesville, Florida, 32610, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

liver tissues during liver surgery

MeSH Terms

Conditions

Liver NeoplasmsCarcinomaIschemia

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Jae-Sung Kim, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2014

First Posted

April 3, 2014

Study Start

October 1, 2014

Primary Completion

June 6, 2019

Study Completion

June 6, 2019

Last Updated

September 25, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)