Cystic EchinococcosisELDHIDANCT05113550
Surgical Treatment of Hepatic Hydatidosis in Elderly Patients
An observational study of Cystic Echinococcosis, run by Universidad de Extremadura at 2 sites in Spain.
Trial summary
Cystic echinococcosis is a clinically complex chronic parasitic disease and a major socioeconomic problem in endemic areas. The safety of liver resection in elderly patients is often debated among medical professionals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Echinococcosis
- What is being tested?
- Surgical remove
- How many people
- 279 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jan 2021to 30 Sep 2021
- 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 with liver hydatidosis carried out at our Hepato-Pancreato-Biliary Surgery Unit
Who may be able to join
- liver hydatid cyst (LHC)
- pathological diagnosis after surgery
- LHC treated by total or partial pericystectomy
Who cannot join
- emergency surgery and simple drainage of cyst
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Universidad de Extremadura- Facultad de Medicina
Badajoz, 06080
Gerardo Blanco-Fernández
Badajoz, 08080
About this study
Cystic echinococcosis is a clinically complex chronic parasitic disease and a major socioeconomic problem in endemic areas. The safety of liver resection in elderly patients is often debated among medical professionals. The investigators analyzed the postoperative morbidity and mortality rates of elderly patients who underwent surgery at our unit.
Read the detailed description
Retrospective observational study from prospective database focused on liver hydatidosis carried out at our Hepato-Pancreato-Biliary Surgery Unit. The study period spanned from January 2006 to October 2020. The study was approved by the Research Ethics Committee of our hospital. An informed consent from the patient was not required since the study was retrospective and observational, and entailed no risk. Seventy years of age was the cutoff age to consider patients as elderly.
Inclusion criteria of patients: liver hydatid cyst (LHC) diagnosed by preoperative computed tomography (CT) or magnetic resonance imaging (MRI) and pathological diagnosis after surgery, and LHC treated by total or partial pericystectomy.
Exclusion criteria of patients: emergency surgery and simple drainage of cyst.
- Conditions
- Cystic Echinococcosis
- Being tested
- Surgical remove
- Medical subject headings
- Echinococcosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical removeOther
liver hydatid cyst (LHC) treated by total or partial pericystectomy
| Study group | Role | What they receive |
|---|---|---|
| Young group | patients < 70 years of age Receives: Other: Surgical remove | |
| Elderly | Patients ≥ 70 years of age) Receives: Other: Surgical remove |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
Patients with postoperative morbidity according to the Clavien-Dindo score 19, "severe complication" (Clavien-Dindo ≥ IIIa) and postoperative mortality
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start1 Jan 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cystic EchinococcosisStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerardo Blanco-Fernández, Universidad de Extremadura
- Investigators
- Gerardo Blanco-Fernández, MD, PhD, Principal investigator, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113550
- Sponsor's protocol ID
- HUB-2021-01
- Acronym
- ELDHIDA
- Status last verified
- Oct 2021
- First submitted
- 28 Oct 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mihmanli M, Idiz UO, Kaya C, Demir U, Bostanci O, Omeroglu S, Bozkurt E. Current status of diagnosis and treatment of hepatic echinococcosis. World J Hepatol. 2016 Oct 8;8(28):1169-1181. doi: 10.4254/wjh.v8.i28.1169.
PubMed 27729953Adamina M, Guller U, Weber WP, Oertli D. Propensity scores and the surgeon. Br J Surg. 2006 Apr;93(4):389-94. doi: 10.1002/bjs.5265.
PubMed 16400708Jaen-Torrejimeno I, Lopez-Guerra D, Prada-Villaverde A, Blanco-Fernandez G. Pattern of Relapse in Hepatic Hydatidosis: Analysis of 238 Cases in a Single Hospital. J Gastrointest Surg. 2020 Feb;24(2):361-367. doi: 10.1007/s11605-019-04163-7. Epub 2019 Feb 26.
PubMed 30809783Jaen-Torrejimeno I, Latorre-Fragua R, Lopez-Guerra D, Rojas-Holguin A, Manuel-Vazquez A, Blanco-Fernandez G, Ramia JM. Jaundice as a clinical presentation in liver hydatidosis increases the risk of postoperative biliary fistula. Langenbecks Arch Surg. 2021 Jun;406(4):1139-1147. doi: 10.1007/s00423-020-02070-z. Epub 2021 Jan 2.
PubMed 33389115Muhtarov M, Rainova I, Tamarozzi F. Treatment of Hepatic Cystic Echinococcosis in Patients from the Southeastern Rhodope Region of Bulgaria in 2004-2013: Comparison of Current Practices with Expert Recommendations. Am J Trop Med Hyg. 2016 Apr;94(4):900-5. doi: 10.4269/ajtmh.15-0620. Epub 2016 Feb 1.
PubMed 26834196
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment of Hepatic Hydatidosis in Elderly Patients
- ClinicalTrials.gov ID
- NCT05113550
- Acronym / sponsor ID
- ELDHIDA / HUB-2021-01
- Conditions
- Cystic Echinococcosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Universidad de ExtremaduraUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 9 Nov 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.
Cystic echinococcosis is a clinically complex chronic parasitic disease and a major socioeconomic problem in endemic areas. The safety of liver resection in elderly patients is often debated among medical professionals. The investigators analyzed the postoperative morbidity and mortality rates of elderly patients who underwent surgery at our unit.
Detailed description
Retrospective observational study from prospective database focused on liver hydatidosis carried out at our Hepato-Pancreato-Biliary Surgery Unit. The study period spanned from January 2006 to October 2020. The study was approved by the Research Ethics Committee of our hospital. An informed consent from the patient was not required since the study was retrospective and observational, and entailed no risk. Seventy years of age was the cutoff age to consider patients as elderly.
Inclusion criteria of patients: liver hydatid cyst (LHC) diagnosed by preoperative computed tomography (CT) or magnetic resonance imaging (MRI) and pathological diagnosis after surgery, and LHC treated by total or partial pericystectomy.
Exclusion criteria of patients: emergency surgery and simple drainage of cyst.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young group | – | Other: Surgical removepatients < 70 years of age |
| Elderly | – | Other: Surgical removePatients ≥ 70 years of age) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with liver hydatidosis carried out at our Hepato-Pancreato-Biliary Surgery Unit
Key inclusion criteria (3 listed)
- liver hydatid cyst (LHC)
- pathological diagnosis after surgery
- LHC treated by total or partial pericystectomy
Key exclusion criteria (1 listed)
- emergency surgery and simple drainage of cyst
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 |
|---|---|---|
| Surgical removeliver hydatid cyst (LHC) treated by total or partial pericystectomy | Other | Elderly, Young group |
Primary outcome
Morbidity
Time frame: 90 days
Patients with postoperative morbidity according to the Clavien-Dindo score 19, "severe complication" (Clavien-Dindo ≥ IIIa) and postoperative mortality
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 Nov 2021.
- Background: PubMed 27729953Mihmanli M, Idiz UO, Kaya C, Demir U, Bostanci O, Omeroglu S, Bozkurt E. Current status of diagnosis and treatment of hepatic echinococcosis. World J Hepatol. 2016 Oct 8;8(28):1169-1181. doi: 10.4254/wjh.v8.i28.1169.
- Background: PubMed 16400708Adamina M, Guller U, Weber WP, Oertli D. Propensity scores and the surgeon. Br J Surg. 2006 Apr;93(4):389-94. doi: 10.1002/bjs.5265.
- Background: PubMed 30809783Jaen-Torrejimeno I, Lopez-Guerra D, Prada-Villaverde A, Blanco-Fernandez G. Pattern of Relapse in Hepatic Hydatidosis: Analysis of 238 Cases in a Single Hospital. J Gastrointest Surg. 2020 Feb;24(2):361-367. doi: 10.1007/s11605-019-04163-7. Epub 2019 Feb 26.
- Background: PubMed 33389115Jaen-Torrejimeno I, Latorre-Fragua R, Lopez-Guerra D, Rojas-Holguin A, Manuel-Vazquez A, Blanco-Fernandez G, Ramia JM. Jaundice as a clinical presentation in liver hydatidosis increases the risk of postoperative biliary fistula. Langenbecks Arch Surg. 2021 Jun;406(4):1139-1147. doi: 10.1007/s00423-020-02070-z. Epub 2021 Jan 2.
- Results publication: PubMed 26834196Muhtarov M, Rainova I, Tamarozzi F. Treatment of Hepatic Cystic Echinococcosis in Patients from the Southeastern Rhodope Region of Bulgaria in 2004-2013: Comparison of Current Practices with Expert Recommendations. Am J Trop Med Hyg. 2016 Apr;94(4):900-5. doi: 10.4269/ajtmh.15-0620. Epub 2016 Feb 1.
- Individual participant dataSharing planned: No
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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.
Gerardo Blanco-Fernández, MD, PhD principal investigator
University of Extremadura
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Echinococcosis, run by Universidad de Extremadura at 2 sites in Spain.
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 3 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 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Morbidity (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05113550, which also lists 5 linked publications.
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 Nov 2021.