Longitudinal Outcomes in Hepatic Resection | NCT02997098

Studies
Longitudinal Outcomes in Hepatic Resection

NCT02997098

Sponsor

Duke University

Status

Withdrawn

Last Update Posted

Jul 31, 2018Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Liver Diseases
Surgery

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study design changed to clinical database only with no research question to be studied.

Expanded Access Info

Start Date

May 4, 2017Actual

Primary Completion Date

May 2037Estimated

Completion Date

May 2037Estimated

First Submitted Date

Dec 15, 2016

First Submission Date that Met QC Criteria

Dec 15, 2016

First Posted Date

Dec 19, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2018

Last Update Posted Date

Jul 31, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients undergoing hepatectomy		Patients undergoing hepatectomy, or liver resection, for a non-transplant indication.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival		10 years

Secondary Outcomes

Measure	Description	Time Frame
Disease-free survival		10 years
Surgical-site infection		3 months
Postoperative bleeding

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients requiring liver resection

Exclusion Criteria:

Patients under the age of 18 years
Patients undergoing liver transplant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing liver resection for non-transplant indications.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sabino Zani, MD	DUHS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duke University Health System		Durham	North Carolina	27710	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided