Longitudinal Outcomes in Hepatic Resection

July 27, 2018 updated by: Duke University

This observational registry of patients undergoing liver surgery collects patients both retrospectively and prospectively. Patients undergoing liver resection for any non-transplant indication will be evaluated for clinical outcomes (such as surgical complications, survival, and disease progression) based on clinical and patient factors (like indication, age, and other treatments for the disease).

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- North Carolina
  - Durham, North Carolina, United States, 27710
    - Duke University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing liver resection for non-transplant indications.

Description

Inclusion Criteria:

Patients requiring liver resection

Exclusion Criteria:

Patients under the age of 18 years
Patients undergoing liver transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Patients undergoing hepatectomy Patients undergoing hepatectomy, or liver resection, for a non-transplant indication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival Time Frame: 10 years	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival Time Frame: 10 years		10 years
Intraoperative blood loss Time Frame: 1 day		1 day
Operative time Time Frame: 1 day		1 day
Surgical-site infection Time Frame: 3 months		3 months
Postoperative bleeding Time Frame: 3 months		3 months
Blood clot Time Frame: 3 months		3 months
Use of other therapy Time Frame: 5 years	e.g., antibiotics in liver abscess, chemotherapy in liver cancer	5 years
Number of segments resected Time Frame: 1 day	If applicable	1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

Principal Investigator: Sabino Zani, MD, DUHS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2017

Primary Completion (Anticipated)

May 1, 2037

Study Completion (Anticipated)

May 1, 2037

Study Registration Dates

First Submitted

December 15, 2016

First Submitted That Met QC Criteria