Liver DiseasesNCT02997098
Longitudinal Outcomes in Hepatic Resection
An observational study of Liver Diseases and Surgery, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases, Surgery
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2017to May 2037
- How long will I take part?
- 10 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing liver resection for non-transplant indications.
Who may be able to join
- Patients requiring liver resection
Who cannot join
- Patients under the age of 18 years
- Patients undergoing liver transplant
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
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).
- Conditions
- Liver Diseases, Surgery
- Keywords
- Hepatectomy
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing hepatectomy | Patients undergoing hepatectomy, or liver resection, for a non-transplant indication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 10 years
Secondary outcomes (8)
Disease-free survival
Measured: 10 years
Surgical-site infection
Measured: 3 months
Postoperative bleeding
Measured: 3 months
Blood clot
Measured: 3 months
Use of other therapy
e.g., antibiotics in liver abscess, chemotherapy in liver cancer
Measured: 5 years
Operative time
Measured: 1 day
Intraoperative blood loss
Measured: 1 day
Number of segments resected
If applicable
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study start4 May 2017
- Primary completionMay 2037 (estimated)
- Study completionMay 2037 (estimated)
Why it stopped: Study design changed to clinical database only with no research question to be studied.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Other
- Enrolment
- 0 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabino Zani, MD, Principal investigator, DUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997098
- Sponsor's protocol ID
- Pro00078618
- Status last verified
- Jul 2018
- First submitted
- 15 Dec 2016
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Outcomes in Hepatic Resection
- ClinicalTrials.gov ID
- NCT02997098
- Acronym / sponsor ID
- Pro00078618
- Conditions
- Liver Diseases, Surgery
- Keywords
- Hepatectomy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study design changed to clinical database only with no research question to be studied.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 4 May 2017 (actual)
- Primary completion
- May 2037 (estimated)
- Study completion
- May 2037 (estimated)
- First posted
- 19 Dec 2016 (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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing hepatectomy | – | –Patients undergoing hepatectomy, or liver resection, for a non-transplant indication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing liver resection for non-transplant indications.
Key inclusion criteria (1 listed)
- Patients requiring liver resection
Key exclusion criteria (2 listed)
- Patients under the age of 18 years
- Patients undergoing liver transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 10 years
8 secondary outcomes
Disease-free survival
Time frame: 10 years
Surgical-site infection
Time frame: 3 months
Postoperative bleeding
Time frame: 3 months
Blood clot
Time frame: 3 months
Use of other therapy
Time frame: 5 years
Operative time
Time frame: 1 day
Intraoperative blood loss
Time frame: 1 day
Number of segments resected
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Individual participant dataSharing planned: No
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Recruiting
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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.
Sabino Zani, MD principal investigator
DUHS
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 Liver Diseases and Surgery, run by Duke University 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 2 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: withdrawn, as of the sponsor's last update on 31 Jul 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
Overall survival (time frame: 10 years). 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 31 Jul 2018.