Clinical trial NCT06612229: Biliary Fistulas in Surgery of Liver Echinococcosis
Official title: Improvement of Methodological Approaches to Diagnostics and Tactics of Treatment of Biliary Fistulas in Surgery of Liver Echinococcosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Echinococcosis, Hepatic
Biliary Fistula
Keywords: Echinococcosis of the liver
Biliary fistula
Conservative surgical treatment
Lead sponsor: Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility criteria: 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\&amp;#39;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.

Primary outcomes:
measure: Measuring the incidence of bile leakage after conservative surgical interventions for liver echinococcosis
timeFrame: 3 months
measure: Measuring the time of closure of biliary fistulas in the postoperative period
timeFrame: 3 months
Secondary outcomes:
measure: Measuring the costs of treating patients with liver echinococcosis
timeFrame: 3 months
measure: Measurement of the quality of life of patients after conservative surgical interventions for liver echinococcosis.
timeFrame: 3 months
Other outcomes:
Locations:
city: Tashkent
country: Uzbekistan
facility: Republican specialized scientific and practical medical center of surgery named after academician V.Vakhidov
Study officials:
References: