Improving surgical treatment for liver echinococcosis with biliary fistulas

Improvement of Methodological Approaches to Diagnostics and Tactics of Treatment of Biliary Fistulas in Surgery of Liver Echinococcosis

This study is testing a new way to improve surgery for people with liver echinococcosis who also have biliary fistulas, using special glue to help fix the problem and see if it leads to better recovery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov (other)
• Locations: 1 site (Tashkent)
• Trial ID: NCT06612229 on ClinicalTrials.gov

What this trial studies

This study aims to enhance surgical outcomes for patients with liver echinococcosis complicated by biliary fistulas. It focuses on optimizing diagnostic methods for early detection of these complications and refining surgical techniques for their management. The intervention involves conservative surgical treatment, including the verification and elimination of biliary fistulas using medical cyanoacrylate glue. The study will gather comprehensive data on surgical procedures and postoperative recovery to assess effectiveness.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals under 18 years old diagnosed with liver echinococcosis requiring conservative surgical treatment.

Not a fit: Patients over 18 years old or those without liver echinococcosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve surgical outcomes and recovery for patients suffering from liver echinococcosis with biliary fistulas.

How similar studies have performed: While there may be limited data on similar approaches, the study's focus on optimizing surgical techniques for a specific complication suggests a novel approach.

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\'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.

Where this trial is running

Tashkent

• Republican specialized scientific and practical medical center of surgery named after academician V.Vakhidov — Tashkent, Uzbekistan (RECRUITING)

Conditions: Echinococcosis, Hepatic, Biliary Fistula, Echinococcosis of the liver, Biliary fistula, Conservative surgical treatment