Hepatic Cystic EchinococcosisNCT07793448
Omentoplasty Versus Tube Drainage for Residual Cavity Management in Complicated Hepatic Cystic Echinococcosis
A study testing omentoplasty and External Tube Drainage in people with Hepatic Cystic Echinococcosis, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This prospective comparative study evaluated two surgical techniques for residual cavity management following conservative surgery for complicated hepatic cystic echinococcosis. Patients undergoing surgery were managed with either omentoplasty or tube drainage. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatic Cystic Echinococcosis
- What is being tested?
- omentoplasty and External Tube Drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2020to 10 Mar 2026
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years.
- Complicated hepatic cystic echinococcosis requiring surgical treatment.
- Cyst diameter ≥8 cm.
- Cysts located in hepatic segments IV, V, VI, VII, or VIII.
- WHO-IWGE CE2 or CE3b cyst stage.
- Presence of at least one complication or high-risk feature, including rupture, adjacent organ involvement, cholangitis, biliary communication, or cyst infection.
- ASA physical status ≤III.
Who cannot join
- WHO-IWGE CE1 or CE3a cyst stage.
- Cysts located in hepatic segments I, II, or III.
- Extensive multiple hepatic cysts.
- Previous surgery for hepatic cystic echinococcosis.
- Malignancy.
- Pregnancy.
- ASA physical status >III.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk University Faculty of Medicine
Erzurum, Erzurum, 25240
About this study
Official title: Omentoplasty Versus Tube Drainage for Residual Cavity Management After Conservative Surgery for Complicated Hepatic Cystic Echinococcosis: A Prospective Comparative Study
This prospective comparative study evaluated two surgical techniques for residual cavity management following conservative surgery for complicated hepatic cystic echinococcosis. Patients undergoing surgery were managed with either omentoplasty or tube drainage. The study aimed to compare postoperative outcomes between the two techniques, with particular emphasis on postoperative complications and residual cavity-related complications. Long-term follow-up was also performed to assess recurrence and other clinical outcomes.
Read the detailed description
Cystic echinococcosis of the liver may be associated with complications such as biliary communication, infection, rupture, cholangitis, and involvement of adjacent structures. Following conservative surgical treatment, appropriate management of the residual hepatic cavity remains an important component of surgical care.
This prospective, single-center comparative study was conducted at Atatürk University Faculty of Medicine and included adult patients undergoing conservative surgery for complicated hepatic cystic echinococcosis. Eligible patients were allocated to residual cavity management with either omentoplasty or tube drainage according to a predetermined alternating allocation strategy.
The study was designed to compare the clinical outcomes of these two residual cavity management techniques. Postoperative outcomes included overall postoperative complications, surgical site infection, biliary fistula, and residual cavity-related complications. Operative characteristics and other relevant perioperative outcomes were also evaluated.
All surgical procedures were performed by the same surgical team using a standardized perioperative approach. Patients received albendazole treatment according to the institutional treatment protocol. Following surgery, patients underwent clinical and radiological follow-up using ultrasonography and/or computed tomography as clinically appropriate. Long-term follow-up was used to evaluate recurrence and other relevant clinical outcomes.
The primary objective of the study was to determine whether the method used for residual cavity management was associated with differences in postoperative outcomes after conservative surgery for complicated hepatic cystic echinococcosis.
- Conditions
- Hepatic Cystic Echinococcosis
- Being tested
- omentoplasty, External Tube Drainage
- Keywords
- Cystic Echinococcosis, Hydatid Cyst, Liver, Omentoplasty, Tube Drainage, Residual Cavity, Conservative Surgery, Biliary Fistula
- Medical subject headings
- Echinococcosis, Biliary Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omentoplastyProcedure or surgery
After conservative surgery for complicated hepatic cystic echinococcosis, the residual cavity was obliterated using a pedicled omental flap (omentoplasty) to reduce dead space and cavity-related complications.
External Tube DrainageProcedure or surgery
After conservative surgery for complicated hepatic cystic echinococcosis, an external tube drain was placed into the residual cavity for postoperative drainage and monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Omentoplasty Group | Experimental | Participants underwent conservative surgery for complicated hepatic cystic echinococcosis followed by omentoplasty for residual cavity management. Receives: Procedure: omentoplasty |
| Tube Drainage Group | Active comparator | Participants underwent conservative surgery for complicated hepatic cystic echinococcosis followed by external tube drainage for residual cavity management. Receives: Procedure: External Tube Drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Residual Cavity-Related Complications
Incidence of postoperative complications related to the residual hepatic cyst cavity, including residual cavity infection, abscess formation, or other cavity-related complications, compared between the omentoplasty and tube drainage groups.
Measured: Up to 30 days after surgery
Secondary outcomes (5)
Postoperative Bile Leakage
Incidence of postoperative bile leakage, defined as clinically evident biliary drainage after surgery, compared between the omentoplasty and tube drainage groups.
Measured: Up to 30 days after surgery
Surgical Site Infection
Incidence of postoperative surgical site infection compared between the omentoplasty and tube drainage groups.
Measured: Up to 30 days after surgery
Overall Postoperative Complications
Incidence of overall postoperative complications compared between the omentoplasty and tube drainage groups
Measured: Up to 30 days after surgery
Operative Time
Duration of surgery from skin incision to completion of skin closure, compared between the omentoplasty and tube drainage groups
Measured: During surgery
Recurrence of Hepatic Cystic Echinococcosis
Comparison of the incidence of hepatic cystic echinococcosis recurrence between the omentoplasty and tube drainage groups during long-term follow-up
Measured: Up to at least 60 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start10 Mar 2020
- Primary completion10 Jun 2021
- Study completion10 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Cystic EchinococcosisStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to two parallel groups undergoing either omentoplasty or tube drainage for residual cavity management following conservative surgery for complicated hepatic cystic echinococcosis.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilal Aydin, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793448
- Sponsor's protocol ID
- ATAUNI-HCE-OPTD-2020
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared due to patient confidentiality and ethical considerations. Aggregate study results will be reported in the planned scientific publication.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omentoplasty Versus Tube Drainage for Residual Cavity Management After Conservative Surgery for Complicated Hepatic Cystic Echinococcosis: A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT07793448
- Acronym / sponsor ID
- ATAUNI-HCE-OPTD-2020
- Conditions
- Hepatic Cystic Echinococcosis
- Keywords
- Cystic Echinococcosis, Hydatid Cyst, Liver, Omentoplasty, Tube Drainage, Residual Cavity, Conservative Surgery, Biliary Fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 28 Aug 2026 (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.
This prospective comparative study evaluated two surgical techniques for residual cavity management following conservative surgery for complicated hepatic cystic echinococcosis. Patients undergoing surgery were managed with either omentoplasty or tube drainage. The study aimed to compare postoperative outcomes between the two techniques, with particular emphasis on postoperative complications and residual cavity-related complications. Long-term follow-up was also performed to assess recurrence and other clinical outcomes.
Detailed description
Cystic echinococcosis of the liver may be associated with complications such as biliary communication, infection, rupture, cholangitis, and involvement of adjacent structures. Following conservative surgical treatment, appropriate management of the residual hepatic cavity remains an important component of surgical care.
This prospective, single-center comparative study was conducted at Atatürk University Faculty of Medicine and included adult patients undergoing conservative surgery for complicated hepatic cystic echinococcosis. Eligible patients were allocated to residual cavity management with either omentoplasty or tube drainage according to a predetermined alternating allocation strategy.
The study was designed to compare the clinical outcomes of these two residual cavity management techniques. Postoperative outcomes included overall postoperative complications, surgical site infection, biliary fistula, and residual cavity-related complications. Operative characteristics and other relevant perioperative outcomes were also evaluated.
All surgical procedures were performed by the same surgical team using a standardized perioperative approach. Patients received albendazole treatment according to the institutional treatment protocol. Following surgery, patients underwent clinical and radiological follow-up using ultrasonography and/or computed tomography as clinically appropriate. Long-term follow-up was used to evaluate recurrence and other relevant clinical outcomes.
The primary objective of the study was to determine whether the method used for residual cavity management was associated with differences in postoperative outcomes after conservative surgery for complicated hepatic cystic echinococcosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned to two parallel groups undergoing either omentoplasty or tube drainage for residual cavity management following conservative surgery for complicated hepatic cystic echinococcosis.
| Arm | Type | Receives |
|---|---|---|
| Omentoplasty Group | Experimental | Procedure: omentoplastyParticipants underwent conservative surgery for complicated hepatic cystic echinococcosis followed by omentoplasty for residual cavity management. |
| Tube Drainage Group | Active comparator | Procedure: External Tube DrainageParticipants underwent conservative surgery for complicated hepatic cystic echinococcosis followed by external tube drainage for residual cavity management. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-80 years.
- Complicated hepatic cystic echinococcosis requiring surgical treatment.
- Cyst diameter ≥8 cm.
- Cysts located in hepatic segments IV, V, VI, VII, or VIII.
- WHO-IWGE CE2 or CE3b cyst stage.
Key exclusion criteria (7 listed)
- WHO-IWGE CE1 or CE3a cyst stage.
- Cysts located in hepatic segments I, II, or III.
- Extensive multiple hepatic cysts.
- Previous surgery for hepatic cystic echinococcosis.
- Malignancy.
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 |
|---|---|---|
| omentoplastyAfter conservative surgery for complicated hepatic cystic echinococcosis, the residual cavity was obliterated using a pedicled omental flap (omentoplasty) to reduce dead space and cavity-related complications. | Procedure or surgery | Omentoplasty Group |
| External Tube DrainageAfter conservative surgery for complicated hepatic cystic echinococcosis, an external tube drain was placed into the residual cavity for postoperative drainage and monitoring. | Procedure or surgery | Tube Drainage Group |
Primary outcome
Postoperative Residual Cavity-Related Complications
Time frame: Up to 30 days after surgery
Incidence of postoperative complications related to the residual hepatic cyst cavity, including residual cavity infection, abscess formation, or other cavity-related complications, compared between the omentoplasty and tube drainage groups.
5 secondary outcomes
Postoperative Bile Leakage
Time frame: Up to 30 days after surgery
Surgical Site Infection
Time frame: Up to 30 days after surgery
Overall Postoperative Complications
Time frame: Up to 30 days after surgery
Operative Time
Time frame: During surgery
Recurrence of Hepatic Cystic Echinococcosis
Time frame: Up to at least 60 months after surgery
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 28 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared due to patient confidentiality and ethical considerations. Aggregate study results will be reported in the planned scientific publication.
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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?
A study testing omentoplasty and External Tube Drainage in people with Hepatic Cystic Echinococcosis, run by Ataturk 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 7 inclusion and 7 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 28 Aug 2026. 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?
Postoperative Residual Cavity-Related Complications (time frame: Up to 30 days after surgery). 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 28 Aug 2026.