Surgical Outcomes Database For Faculty of Hepatopancreatic Biliary Surgery

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
David Iannitti, Carolinas Healthcare System Identifier:
First received: August 2, 2012
Last updated: February 3, 2015
Last verified: February 2015

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.

Condition Intervention
Cancer of Liver
Pancreatic Cancer
Biliary Tract Cancer
Procedure: HPB Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surgical Outcomes Database for Faculty of Hepatopancreatico Biliary Surgery

Resource links provided by NLM:

Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:
  • Surgical Outcome [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Quality of life evaluation after surgical intervention.

Estimated Enrollment: 300
Study Start Date: April 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HPB Surgery
Patients undergoing surgical HPB procedures
Procedure: HPB Surgery
Hepatopancreatico Biliary Surgery

Detailed Description:

The concept of disease management stems from a logical evolution in the field of outcomes applications by healthcare provides is the concept of disease management. The basic premise of disease management is that there is a more optimal way to manage patients in order to reduce costs and improve health outcomes. The data collected from patient-reported outcomes allows the physician and staff to screen for specific health conditions, monitor patients individually, evaluate outcomes for specific groups, assess quality of care, determine impact of intervention and predict outcomes. Most of the follow-up results from this study will be obtained directly from the patient during follow-up visits, but other information may be obtained from medical records.

Evaluation of the surgical database Application will identify both patient and procedural variables that can predict adverse outcomes.


Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hepatopancreatico Biliary surgical patients.


Inclusion Criteria:

  • Patients that are Hepatopancreatico Biliary surgical patients.

Exclusion Criteria:

  • Patients that are not Hepatopancreatico Biliary surgical patients.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01657383

United States, North Carolina
Carolinas Health System
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Carolinas Healthcare System
Principal Investigator: David A Iannitti, MD Carolinas Healthcare System
  More Information

No publications provided

Responsible Party: David Iannitti, MD, FACS, Carolinas Healthcare System Identifier: NCT01657383     History of Changes
Other Study ID Numbers: 04-12-02E
Study First Received: August 2, 2012
Last Updated: February 3, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Liver Neoplasms
Pancreatic Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Liver Diseases
Neoplasms by Site
Pancreatic Diseases processed this record on October 08, 2015