Biliary Fistulas in Surgery of Liver Echinococcosis

NCT06612229 | Recruiting

• 1 other identifier: 27022024
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Echinococcosis, Hepatic; Biliary Fistula

Keywords

Echinococcosis of the liver; Biliary fistula; Conservative surgical treatment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Measuring the costs of treating patients with liver echinococcosis

  3 months

• Measurement of the quality of life of patients after conservative surgical interventions for liver echinococcosis.

  3 months

Study Arms (1)

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

Interventions

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

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.

operation for liver echinococcosis complicated by a biliary fistula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age under 18 years;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Republican specialized scientific and practical medical center of surgery named after academician V.Vakhidov

Tashkent, 100000, Uzbekistan

RECRUITING

MeSH Terms

Conditions

Echinococcosis, Hepatic; Biliary Fistula

Condition Hierarchy (Ancestors)

Echinococcosis; Cestode Infections; Helminthiasis; Parasitic Diseases; Infections; Liver Diseases, Parasitic; Liver Diseases; Digestive System Diseases; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: September 25, 2024
• Study Start: October 22, 2023
• Primary Completion (Estimated): September 22, 2026
• Study Completion (Estimated): December 23, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-09

Locations

UZ (1)