NCT02997098

Brief Summary

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).

Trial Health

50
Monitor

Trial Health Score

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

Timeline
132mo left

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
May 2017May 2037

First Submitted

Initial submission to the registry

December 15, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

May 4, 2017

Completed
20 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2037

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2037

Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

20 years

First QC Date

December 15, 2016

Last Update Submit

July 27, 2018

Conditions

Liver DiseasesSurgery

Keywords

Hepatectomy

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    10 years

Secondary Outcomes (8)

  • Disease-free survival

    10 years

  • Surgical-site infection

    3 months

  • Postoperative bleeding

    3 months

  • Blood clot

    3 months

  • Use of other therapy

    5 years

  • +3 more secondary outcomes

Study Arms (1)

Patients undergoing hepatectomy

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

Eligibility Criteria

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

Patients undergoing liver resection for non-transplant indications.

You may qualify if:

  • Patients requiring liver resection

You may not qualify if:

  • Patients under the age of 18 years
  • Patients undergoing liver transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Sabino Zani, MD

    DUHS

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2016

First Posted

December 19, 2016

Study Start

May 4, 2017

Primary Completion (Estimated)

May 1, 2037

Study Completion (Estimated)

May 1, 2037

Last Updated

July 31, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)