Hydatid Cyst, HepaticNCT05989516
Surgical Treatment of Hydatid Liver Disease
An observational study of Hydatid Cyst, Hepatic, run by University Hospital for Surgical Diseases St. Naum Ohridsk i- Skopje at 1 site in North Macedonia.
Trial summary
The goal of this observational study is to show that cyst extraction with pericyst reduction and omentopexy is a suitable treatment for liver hydatid disease caused by E.Granulossus with a low rate of complication and recurrence. Read more about this study
- Who is it for?
- Ages 16 to 99 years
- Conditions the study is for
- Hydatid Cyst, Hepatic
- How many people
- 72 participants
- Where
- 1 siteNorth Macedonia
- Study dates
- 1 Feb 2021to 1 Mar 2023
- 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 16 to 99 years
- All sexes
- Child, Adult, Older adult
Study population: We have analyzed 72 patients diagnosed with liver hydatid disease for a period of 10 years from January 2006 until January 2017 treated surgically by cyst extraction, pericystectomy, and omentopexy.
Who may be able to join
- hydatid liver disease
Who cannot join
- hydatid disease present outside the liver
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cyst Extraction With Pericyst Reduction and Omentopexy as a Treatment of Choice for Hydatid Liver Disease Caused by E. Granulosus: Retrospective Observational Review of a Single Center Experience
The goal of this observational study is to show that cyst extraction with pericyst reduction and omentopexy is a suitable treatment for liver hydatid disease caused by E.Granulossus with a low rate of complication and recurrence.
- Conditions
- Hydatid Cyst, Hepatic
- Medical subject headings
- Echinococcosis, Hepatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative complications
Listing of complications according to Clavien -Dindo classification
Measured: one month
Secondary outcomes (1)
Recurrence rate
Recurrence rate of hydatid disease in patients
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Feb 2021
- Primary completion1 Feb 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydatid Cyst, HepaticStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital for Surgical Diseases St. Naum Ohridsk i- Skopje
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Zafirovikj, University Hospital for Surgical Diseases St. Naum Ohridsk i- Skopje
- Investigators
- Elena Zafirovikj, MD, Principal investigator, UHSD St. Naum Ohridski
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989516
- Sponsor's protocol ID
- 001/0/2023
- Status last verified
- Aug 2023
- First submitted
- 4 Aug 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyst Extraction With Pericyst Reduction and Omentopexy as a Treatment of Choice for Hydatid Liver Disease Caused by E. Granulosus: Retrospective Observational Review of a Single Center Experience
- ClinicalTrials.gov ID
- NCT05989516
- Acronym / sponsor ID
- 001/0/2023
- Conditions
- Hydatid Cyst, Hepatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospital for Surgical Diseases St. Naum Ohridsk i- SkopjeUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 14 Aug 2023 (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.
The goal of this observational study is to show that cyst extraction with pericyst reduction and omentopexy is a suitable treatment for liver hydatid disease caused by E.Granulossus with a low rate of complication and recurrence.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- We have analyzed 72 patients diagnosed with liver hydatid disease for a period of 10 years from January 2006 until January 2017 treated surgically by cyst extraction, pericystectomy, and omentopexy.
Key inclusion criteria (1 listed)
- hydatid liver disease
Key exclusion criteria (1 listed)
- hydatid disease present outside the liver
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
Post operative complications
Time frame: one month
Listing of complications according to Clavien -Dindo classification
1 secondary outcome
Recurrence rate
Time frame: 5 years
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 29 Aug 2023.
- 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.
Elena Zafirovikj, MD principal investigator
UHSD St. Naum Ohridski
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 Hydatid Cyst, Hepatic, run by University Hospital for Surgical Diseases St. Naum Ohridsk i- Skopje at 1 site in North Macedonia.
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 29 Aug 2023. 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 North Macedonia. 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?
Post operative complications (time frame: one month). 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 29 Aug 2023.