Liver AngiomaNCT04709718
Surgical Management of Giant Hepatic Hemangioma
An observational study of Liver Angioma, run by Université de Sousse.
Trial summary
Hepatic hemangiomas are the commonest benign mesenchymal lesions of the liver. Most of these lesions are asymptomatic. Giant hepatic hemangiomas (GHH) (> 10 cm) are often symptomatic and require surgical intervention. Read more about this study
- Who is it for?
- Ages 15 to 90 years
- Conditions the study is for
- Liver Angioma
- What is being tested?
- hepatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 2 Jan 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 15 to 90 years
- All sexes
- Child, Adult, Older adult
Study population: patient with symptomatic geant liver hemangioma
Who may be able to join
- Radiological diagnosis of geant liver hamangioma.
Who cannot join
- Radiological diagnosis of liver hemangioma less than 10cm.
About this study
Official title: Surgical Management of Giant Hepatic Hemangioma: a 10-year Single Center Experience
Hepatic hemangiomas are the commonest benign mesenchymal lesions of the liver. Most of these lesions are asymptomatic. Giant hepatic hemangiomas (GHH) (> 10 cm) are often symptomatic and require surgical intervention. This study aimed to describe the clinical findings, risk factors, diagnostic approach and management of GHH.
Read the detailed description
Hepatic hemangiomas are the most common benign tumors of the liver with the incidence of 0.4 to 20% . They are most often discovered incidentally on imaging studies. Typical hemangiomas usually do not increase in size over time and therefore are unlikely to cause symptoms. Giant hepatic hemangiomas (GHH) are defined as hemangiomas larger than 5 cm . They are usually responsible for overt clinical symptoms and complications consisting, most often, of upper abdominal pain, hemorrhage, biliary compression, or a consumptive coagulopathy that may require prompt surgical intervention or other treatments . Management of liver hemangiomas ranges from close observation to surgery depending upon the site, size and symptoms .
It is widely accepted that intervention is indicated only for symptomatic hemangiomas. Surgical resection is indicated in patients with abdominal complaints or complications, or when diagnosis remains inconclusive. The ideal surgical treatment for GHH is still controversial. Enucleation is the preferred surgical method based on the existing literature. In this study, we report our 17-year experience of clinical management of GHH.
- Conditions
- Liver Angioma
- Being tested
- hepatectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatectomyProcedure or surgery
liver resection taking over the liver hemangioma
| Study group | Role | What they receive |
|---|---|---|
| churgery of geant liver hemangioma | Not described Receives: Procedure: hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patient getting good result after surgery
patient asymptomatic after surgery or not
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 posted14 Jan 2021
- Study start1 Jan 2008
- Primary completion29 Jun 2019
- Study completion2 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver AngiomaStudies of the same condition, open and under way.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sousse
- Sponsor type
- University, hospital or other
- Collaborators
- Sahloul Hospital of Sousse
- Responsible party
- Principal investigator, ammar houssem, Université de Sousse
- Investigators
- waad farhat, doctor, Study director, university of sousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709718
- Sponsor's protocol ID
- U23464
- Status last verified
- Jan 2021
- First submitted
- 1 Jan 2021
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Management of Giant Hepatic Hemangioma: a 10-year Single Center Experience
- ClinicalTrials.gov ID
- NCT04709718
- Acronym / sponsor ID
- U23464
- Conditions
- Liver Angioma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Université de SousseUniversity, hospital or other
- Collaborators
- Sahloul Hospital of Sousse
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 29 Jun 2019 (actual)
- Study completion
- 2 Jan 2020 (actual)
- First posted
- 14 Jan 2021 (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.
Hepatic hemangiomas are the commonest benign mesenchymal lesions of the liver. Most of these lesions are asymptomatic. Giant hepatic hemangiomas (GHH) (> 10 cm) are often symptomatic and require surgical intervention. This study aimed to describe the clinical findings, risk factors, diagnostic approach and management of GHH.
Detailed description
Hepatic hemangiomas are the most common benign tumors of the liver with the incidence of 0.4 to 20% . They are most often discovered incidentally on imaging studies. Typical hemangiomas usually do not increase in size over time and therefore are unlikely to cause symptoms. Giant hepatic hemangiomas (GHH) are defined as hemangiomas larger than 5 cm . They are usually responsible for overt clinical symptoms and complications consisting, most often, of upper abdominal pain, hemorrhage, biliary compression, or a consumptive coagulopathy that may require prompt surgical intervention or other treatments . Management of liver hemangiomas ranges from close observation to surgery depending upon the site, size and symptoms .
It is widely accepted that intervention is indicated only for symptomatic hemangiomas. Surgical resection is indicated in patients with abdominal complaints or complications, or when diagnosis remains inconclusive. The ideal surgical treatment for GHH is still controversial. Enucleation is the preferred surgical method based on the existing literature. In this study, we report our 17-year experience of clinical management of GHH.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| churgery of geant liver hemangioma | – | Procedure: hepatectomy |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patient with symptomatic geant liver hemangioma
Key inclusion criteria (1 listed)
- Radiological diagnosis of geant liver hamangioma.
Key exclusion criteria (1 listed)
- Radiological diagnosis of liver hemangioma less than 10cm.
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 |
|---|---|---|
| hepatectomyliver resection taking over the liver hemangioma | Procedure or surgery | churgery of geant liver hemangioma |
Primary outcome
number of patient getting good result after surgery
Time frame: 1 year
patient asymptomatic after surgery or not
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 14 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
waad farhat, doctor study director
university of sousse
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Angioma, run by Université de Sousse.
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 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
number of patient getting good result after surgery (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 14 Jan 2021.