Hemangioma LiverNCT04669314
Surgical Approach in Liver Hemangiomas
An observational study of Hemangioma Liver, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Operations performed for liver hemangioma between January 2017 and December 2018 will be retrospectively analyzed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemangioma Liver
- What is being tested?
- Liver resection or enucleation for liver hemangioma
- Type of treatment
- Surgery or procedure
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2020to 30 Oct 2020
- 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
- Adult, Older adult
Study population: Patients underwent surgery for liver hemangioma between 2007 and 2018 at Ankara University Hospitals
Who may be able to join
- Patients underwent surgery for liver hemangioma
Who cannot join
- Cases lacking of more than 20% of critical data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Approach in Liver Hemangiomas With Special Emphasis on Lesion Diameter and Type of Surgery
Operations performed for liver hemangioma between January 2017 and December 2018 will be retrospectively analyzed.
Read the detailed description
Operations performed for liver hemangioma at Ankara University Hospitals will be retrospectively analyzed. Patient and disease characteristics including demographics, laboratory tests, imaging studies, type of surgical approach and outcomes including postoperative laboratory tests, record of complications, duration of hospital stay will be reviewed. Complications were classified according to Clavien-Dindo classification. The patients were informed about the surgeries in advance and their informed consents about surgeries and data collection for scientific purposes were obtained. Datafile will be anonymized before analysis and original file will be destroyed. Outcomes such as complications, hospital stay, blood transfusion and mortality will be compared between groups created according to type of surgery, lesion size, preoperative laboratory values and demographic features. Variables for prediction of better outcomes are expected to be discovered.
- Conditions
- Hemangioma Liver
- Being tested
- Liver resection or enucleation for liver hemangioma
- Keywords
- hemangioma, liver resection, enucleation
- Medical subject headings
- Hemangioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver resection or enucleation for liver hemangiomaProcedure or surgery
Operations in which the hemangioma is selectively removed from the liver parenchyma border are named enucleation, and the operations in which the hemangioma is removed anatomically or non-anatomically with some liver parenchyma surrounding it are named liver resection
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Complications after surgery for hemangioma will be collected from records and and will be classified according to 'The Clavien-Dindo Classification of Surgical Complications'. The classification grades are ranging between Grade 1(better) which indicates minor deviation from normal postoperative course and Grade 5 (worst) which means death as a complication.
Measured: Complications reported within 3 months after surgery will be evaluated within 15 days after completion of data collection
Secondary outcomes (2)
Hospital stay
Length of hospital stay postoperatively
Measured: Hospital stay starting with operation and ends with discharge will be compared within 15 days after completion of data collection
Transfusion
Rate of erythrocyte transfusion
Measured: Erythrocyte transfusion during surgery will be analyzed within 15 days after completion of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start1 Oct 2020
- Primary completion20 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemangioma LiverStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Retrospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elvan Onur Kirimker, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669314
- Sponsor's protocol ID
- AUTF-Hemangioma
- Status last verified
- Dec 2020
- First submitted
- 2 Dec 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study protocol will be seen on clicaltrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Approach in Liver Hemangiomas With Special Emphasis on Lesion Diameter and Type of Surgery
- ClinicalTrials.gov ID
- NCT04669314
- Acronym / sponsor ID
- AUTF-Hemangioma
- Conditions
- Hemangioma Liver
- Keywords
- hemangioma, liver resection, enucleation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 16 Dec 2020 (actual)
- 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.
Operations performed for liver hemangioma between January 2017 and December 2018 will be retrospectively analyzed.
Detailed description
Operations performed for liver hemangioma at Ankara University Hospitals will be retrospectively analyzed. Patient and disease characteristics including demographics, laboratory tests, imaging studies, type of surgical approach and outcomes including postoperative laboratory tests, record of complications, duration of hospital stay will be reviewed. Complications were classified according to Clavien-Dindo classification. The patients were informed about the surgeries in advance and their informed consents about surgeries and data collection for scientific purposes were obtained. Datafile will be anonymized before analysis and original file will be destroyed. Outcomes such as complications, hospital stay, blood transfusion and mortality will be compared between groups created according to type of surgery, lesion size, preoperative laboratory values and demographic features. Variables for prediction of better outcomes are expected to be discovered.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients underwent surgery for liver hemangioma between 2007 and 2018 at Ankara University Hospitals
Key inclusion criteria (1 listed)
- Patients underwent surgery for liver hemangioma
Key exclusion criteria (1 listed)
- Cases lacking of more than 20% of critical data
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 |
|---|---|---|
| Liver resection or enucleation for liver hemangiomaOperations in which the hemangioma is selectively removed from the liver parenchyma border are named enucleation, and the operations in which the hemangioma is removed anatomically or non-anatomically with some liver parenchyma surrounding it are named liver resection | Procedure or surgery | – |
Primary outcome
Complications
Time frame: Complications reported within 3 months after surgery will be evaluated within 15 days after completion of data collection
Complications after surgery for hemangioma will be collected from records and and will be classified according to 'The Clavien-Dindo Classification of Surgical Complications'. The classification grades are ranging between Grade 1(better) which indicates minor deviation from normal postoperative course and Grade 5 (worst) which means death as a complication.
2 secondary outcomes
Hospital stay
Time frame: Hospital stay starting with operation and ends with discharge will be compared within 15 days after completion of data collection
Transfusion
Time frame: Erythrocyte transfusion during surgery will be analyzed within 15 days after completion of data collection
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 16 Dec 2020.
- Individual participant dataSharing planned: Undecided. Study protocol will be seen on clicaltrials.gov
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hemangioma Liver, run by Ankara University at 1 site in Turkey (Türkiye).
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 16 Dec 2020. 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 Turkey (Türkiye). 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?
Complications (time frame: Complications reported within 3 months after surgery will be evaluated within 15 days after completion of data collection). 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 16 Dec 2020; AzTrials last refreshed its copy on 2 Nov 2026.