Cancer of LiverNCT01657383
Surgical Outcomes Database For Faculty of Hepatopancreatic Biliary Surgery
An observational study of Cancer of Liver and Pancreatic Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer of Liver, Pancreatic Cancer, Biliary Tract Cancer
- What is being tested?
- HPB Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hepatopancreatico Biliary surgical patients.
Who may be able to join
- Patients that are Hepatopancreatico Biliary surgical patients.
Who cannot join
- Patients that are not Hepatopancreatico Biliary surgical patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Health System
Charlotte, North Carolina, 28204
About this study
Official title: Surgical Outcomes Database for Faculty of Hepatopancreatico Biliary Surgery
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.
Read the 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.
- Conditions
- Cancer of Liver, Pancreatic Cancer, Biliary Tract Cancer
- Being tested
- HPB Surgery
- Medical subject headings
- Liver Neoplasms, Pancreatic Neoplasms, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPB SurgeryProcedure or surgery
Hepatopancreatico Biliary Surgery
| Study group | Role | What they receive |
|---|---|---|
| Hepatopancreaticobiliary (HPB) Surgery Patients | Patients undergoing surgical HPB procedures Receives: Procedure: HPB Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Outcome
Quality of life evaluation after surgical intervention.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of LiverStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David A Iannitti, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657383
- Sponsor's protocol ID
- 04-12-02E
- Status last verified
- Jul 2017
- First submitted
- 2 Aug 2012
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Outcomes Database for Faculty of Hepatopancreatico Biliary Surgery
- ClinicalTrials.gov ID
- NCT01657383
- Acronym / sponsor ID
- 04-12-02E
- Conditions
- Cancer of Liver, Pancreatic Cancer, Biliary Tract Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 6 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatopancreaticobiliary (HPB) Surgery Patients | – | Procedure: HPB SurgeryPatients undergoing surgical HPB procedures |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hepatopancreatico Biliary surgical patients.
Key inclusion criteria (1 listed)
- Patients that are Hepatopancreatico Biliary surgical patients.
Key exclusion criteria (1 listed)
- Patients that are not Hepatopancreatico Biliary surgical patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPB SurgeryHepatopancreatico Biliary Surgery | Procedure or surgery | Hepatopancreaticobiliary (HPB) Surgery Patients |
Primary outcome
Surgical Outcome
Time frame: 1 year
Quality of life evaluation after surgical intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Iannitti, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of Liver and Pancreatic Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Outcome (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.