NCT01657383

Brief Summary

The collection of data regarding patient outcomes after surgical intervention creates imperative knowledge to include surgeon performance, cost analysis, base for surgical research and publication, which in turn assist surgeons to improve the standard of care utilizing evidence-based practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

April 27, 2022

Status Verified

July 1, 2017

Enrollment Period

4.7 years

First QC Date

August 2, 2012

Last Update Submit

April 20, 2022

Conditions

Cancer of LiverPancreatic CancerBiliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

  • Surgical Outcome

    Quality of life evaluation after surgical intervention.

    1 year

Study Arms (1)

Hepatopancreaticobiliary (HPB) Surgery Patients

Patients undergoing surgical HPB procedures

Procedure: HPB Surgery

Interventions

HPB SurgeryPROCEDURE

Hepatopancreatico Biliary Surgery

Hepatopancreaticobiliary (HPB) Surgery Patients

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hepatopancreatico Biliary surgical patients.

You may qualify if:

  • Patients that are Hepatopancreatico Biliary surgical patients.

You may not qualify if:

  • Patients that are not Hepatopancreatico Biliary surgical patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carolinas Health System

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Liver NeoplasmsPancreatic NeoplasmsBiliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesBiliary Tract Diseases

Study Officials

  • David A Iannitti, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 2, 2012

First Posted

August 6, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2016

Study Completion

February 1, 2017

Last Updated

April 27, 2022

Record last verified: 2017-07

Locations

US(1)