Biliary Fistulas in Surgery of Liver Echinococcosis (BFISOLE)

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.

Study Overview

• Status: Recruiting
• Conditions: Biliary Fistula; Echinococcosis, Hepatic
• Intervention / Treatment: Procedure: Conservative surgical treatment of liver echinococcosis, verification of occult biliary fistulas and their elimination by weaving and using medical cyanoacrylate glue

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uzbekistan
  • Tashkent, Uzbekistan, 100000
    • Recruiting
    • Republican specialized scientific and practical medical center of surgery named after academician V.Vakhidov
    • Contact: Azam Babadjanov, Professor; Phone Number: +998901751703; Email: azam746@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: operation for liver echinococcosis complicated by a biliary fistula

Procedure: Conservative surgical treatment of liver echinococcosis, verification of occult biliary fistulas and their elimination by weaving and using medical cyanoacrylate glue; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	3 months

Collaborators and Investigators

• Sponsor: Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2023
• Primary Completion (Estimated): September 22, 2026
• Study Completion (Estimated): December 23, 2026

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: September 21, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Biliary fistula; Echinococcosis of the liver; Conservative surgical treatment
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Infections; Digestive System Diseases; Liver Diseases; Parasitic Diseases; Cestode Infections; Helminthiasis; Digestive System Fistula; Fistula; Liver Diseases, Parasitic; Pathological Conditions, Signs and Symptoms; Echinococcosis; Biliary Fistula; Echinococcosis, Hepatic
• Other Study ID Numbers: 27022024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No