Echinococcosis, HepaticBFISOLENCT06612229
Biliary Fistulas in Surgery of Liver Echinococcosis
A study testing Conservative surgical treatment of liver echinococcosis, verification of occult biliary fistulas and their elimination by weaving and using medical cyanoacrylate glue in people with Echinococcosis, Hepatic and Biliary Fistula, run by Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov at 1 site in Uzbekistan.
Trial summary
The objective of the study is to improving the results of surgical treatment of liver echinococcosis complicated by biliary fistula by optimizing diagnostic approaches to early verification of this complication and improving the tactical and technical aspects of its elimination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Echinococcosis, Hepatic, Biliary Fistula
- What is being tested?
- Conservative surgical treatment of liver echinococcosis, verification of occult biliary fistulas and their elimination by weaving and using medical cyanoacrylate glue
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUzbekistan
- Study dates
- 22 Oct 2023to 23 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age under 18 years;
- Informed consent for inclusion in the study;
- The presence of liver echinococcosis, for which conservative surgical treatment will be performed;
- The presence of the entire spectrum of necessary preoperative diagnostic measures;
- A full description of all stages of surgical intervention, indicating the type of intervention (open or laparoscopic surgery, location and size of the echinococcal cyst in the liver, type of antiparasitic treatment, presence or absence of a biliary fistula in the residual cavity, actions taken in relation to the fistula, the option of eliminating the residual cavity and drainage;
- Availability of objective data on the characteristics of the postoperative course, including dynamic indicators of the patient\'s condition, temperature, amount and nature of discharge through the drainage, the time of drainage removal, the type of complications (if any) and the method of their treatment, the duration of the hospital period, data on the characteristics of the posthospital period up to 3 months of observation;
- Absence of concomitant pathology that may affect the outcome of the surgery.
Who cannot join
- Age under 18 years;
- Refusal to participate in the study;
- Extrahepatic echinococcosis without liver damage;
- Absence of the full range of preoperative diagnostic data;
- Difficulties with objective analysis of the features of the performed surgical treatment;
- Incomplete data on monitoring the postoperative hospital and remote (up to 3 months) period;
- The presence of concomitant pathology that may affect the outcome of the operation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uzbekistan1 site, 1 recruiting
- Recruiting
Republican specialized scientific and practical medical center of surgery named after academician V.Vakhidov
Tashkent, 100000
Azam Babadjanov, Professor, +998901751703, azam746@mail.ru
About this study
Official title: Improvement of Methodological Approaches to Diagnostics and Tactics of Treatment of Biliary Fistulas in Surgery of Liver Echinococcosis
The objective of the study is to improving the results of surgical treatment of liver echinococcosis complicated by biliary fistula by optimizing diagnostic approaches to early verification of this complication and improving the tactical and technical aspects of its elimination.
- Conditions
- Echinococcosis, Hepatic, Biliary Fistula
- Being tested
- Conservative surgical treatment of liver echinococcosis, verification of occult biliary fistulas and their elimination by weaving and using medical cyanoacrylate glue
- Keywords
- Echinococcosis of the liver, Biliary fistula, Conservative surgical treatment
- Medical subject headings
- Echinococcosis, Hepatic, Biliary Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative surgical treatment of liver echinococcosis, verification of occult biliary fistulas and their elimination by weaving and using medical cyanoacrylate glueProcedure or surgery
In conservative surgical operations for liver echinococcosis, the biliary fistula is identified, onto which a U-shaped suture is applied, after which medical cyanoacrylate glue is applied between the suture stitches to the fibrous capsule in the fistula area and the suture threads are tied.
| Study group | Role | What they receive |
|---|---|---|
| operation for liver echinococcosis complicated by a biliary fistula | Other | Not described Receives: Procedure: Conservative surgical treatment of liver echinococcosis, verification of occult biliary fistulas and their elimination by weaving and using medical cyanoacrylate glue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the incidence of bile leakage after conservative surgical interventions for liver echinococcosis
assessing the effectiveness of the method for eliminating biliary fistulas in the fibrous capsule during organ-preserving surgeries for liver echinococcosis, characterized by creating a two-level strengthening of the fistula area by applying U-shaped sutures and a cyanoacrylate adhesive composition
Measured: 3 months
Measuring the time of closure of biliary fistulas in the postoperative period
In the group of patients with the development of biliary fistulas after surgery, the time of their closure in days will be studied
Measured: 3 months
Secondary outcomes (2)
Measuring the costs of treating patients with liver echinococcosis
Economic costs will be assessed for patients with liver echinococcosis who undergo conservative surgical interventions, taking into account the absence or development of bile leakage in the postoperative period
Measured: 3 months
Measurement of the quality of life of patients after conservative surgical interventions for liver echinococcosis.
The quality of life will be analyzed using the SF-36 (The 36-Item Short Form Survey) questionnaire in patients after conservative surgical interventions, taking into account the absence or development of bile leakage in the postoperative period. It stems from a study called the Medical Outcomes Study for the objective measure of the quality of life. Scores for the various domains are transformed and combined using a scoring key to obtain a total score indicating a range from low to high quality of life (from 0 to 100 points). Scores for two components, the physical component and the mental component, can also be calculated.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start22 Oct 2023
- Primary completion22 Sep 2026 (estimated)
- Study completion23 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Echinococcosis, 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azam Babadjanov, Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612229
- Sponsor's protocol ID
- 27022024
- Acronym
- BFISOLE
- Status last verified
- Sep 2025
- First submitted
- 27 Feb 2024
- Last updated
- 30 Dec 2025
- Results posted
- 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 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Methodological Approaches to Diagnostics and Tactics of Treatment of Biliary Fistulas in Surgery of Liver Echinococcosis
- ClinicalTrials.gov ID
- NCT06612229
- Acronym / sponsor ID
- BFISOLE / 27022024
- Conditions
- Echinococcosis, Hepatic, Biliary Fistula
- Keywords
- Echinococcosis of the liver, Biliary fistula, Conservative surgical treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. VakhidovUniversity, hospital or other
- Study start
- 22 Oct 2023 (actual)
- Primary completion
- 22 Sep 2026 (estimated)
- Study completion
- 23 Dec 2026 (estimated)
- First posted
- 25 Sep 2024 (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 objective of the study is to improving the results of surgical treatment of liver echinococcosis complicated by biliary fistula by optimizing diagnostic approaches to early verification of this complication and improving the tactical and technical aspects of its elimination.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| operation for liver echinococcosis complicated by a biliary fistula | Other | Procedure: Conservative surgical treatment of liver echinococcosis, verification of occult biliary fistulas and their elimination by weaving and using medical cyanoacrylate glue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age under 18 years;
- Informed consent for inclusion in the study;
- The presence of liver echinococcosis, for which conservative surgical treatment will be performed;
- The presence of the entire spectrum of necessary preoperative diagnostic measures;
- A full description of all stages of surgical intervention, indicating the type of intervention (open or laparoscopic surgery, location and size of the echinococcal cyst in the liver, type of antiparasitic treatment, presence or absence of a biliary fistula in the residual cavity, actions taken in relation to the fistula, the option of eliminating the residual cavity and drainage;
Key exclusion criteria (7 listed)
- Age under 18 years;
- Refusal to participate in the study;
- Extrahepatic echinococcosis without liver damage;
- Absence of the full range of preoperative diagnostic data;
- Difficulties with objective analysis of the features of the performed surgical treatment;
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 |
|---|---|---|
| Conservative surgical treatment of liver echinococcosis, verification of occult biliary fistulas and their elimination by weaving and using medical cyanoacrylate glueIn conservative surgical operations for liver echinococcosis, the biliary fistula is identified, onto which a U-shaped suture is applied, after which medical cyanoacrylate glue is applied between the suture stitches to the fibrous capsule in the fistula area and the suture threads are tied. | Procedure or surgery | operation for liver echinococcosis complicated by a biliary fistula |
Primary outcome
Measuring the incidence of bile leakage after conservative surgical interventions for liver echinococcosis
Time frame: 3 months
assessing the effectiveness of the method for eliminating biliary fistulas in the fibrous capsule during organ-preserving surgeries for liver echinococcosis, characterized by creating a two-level strengthening of the fistula area by applying U-shaped sutures and a cyanoacrylate adhesive composition
Measuring the time of closure of biliary fistulas in the postoperative period
Time frame: 3 months
In the group of patients with the development of biliary fistulas after surgery, the time of their closure in days will be studied
2 secondary outcomes
Measuring the costs of treating patients with liver echinococcosis
Time frame: 3 months
Measurement of the quality of life of patients after conservative surgical interventions for liver echinococcosis.
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- 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.
Republican specialized scientific and practical medical center of surgery named after academician V.Vakhidov
Tashkent, Uzbekistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative surgical treatment of liver echinococcosis, verification of occult biliary fistulas and their elimination by weaving and using medical cyanoacrylate glue in people with Echinococcosis, Hepatic and Biliary Fistula, run by Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov at 1 site in Uzbekistan.
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: looking for participants now, as of the sponsor's last update on 30 Dec 2025. 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 Uzbekistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring the incidence of bile leakage after conservative surgical interventions for liver echinococcosis (time frame: 3 months). The study lists 2 primary outcomes in all. 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 30 Dec 2025.