Presentation of Protoscolexes and Acephalocysts in the Fibrous Capsule Area of the Liver With Echinococcosis

Echinococcosis, Hepatic Clinical Trial

— PAFCLE  

Official title:

Presentation of Protoscolexes and Acephalocysts in the Fibrous Capsule Area of the Liver With Echinococcosis During Organ-preserving Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06316154
• Other study ID #: 12032024
• Status: Recruiting
• Start date: October 22, 2023
• Est. completion date: December 22, 2024

Study information

• Verified date: March 2024
• Source: Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of the study is to determine the presence of germinal elements of echinococcosis in the liver parenchyma next to and in the thickness of the fibrous capsule of hydatid cysts.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 22, 2024
• Est. primary completion date: October 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Presence of primary or recurrent liver echinococcosis disease requiring surgical treatment
• Cyst diametr >5 cm;
• Performing one of the surgical treatment of liver echinococcosis with intraoperative sampling of part of the fibrous capsule with or without adjacent liver tissue for research;
• Signed informed consent of patients for inclusion in the study;

Exclusion Criteria:

• Liver echinococcosis with cysts less than 5 cm in diametr;
• Presence of severe concomitant disorders

Related Conditions & MeSH terms

• Echinococcosis, Hepatic

Intervention

Procedure:
• Echinococcectomy
Echinococcectomy with subsequent pathomorphological analysis of liver parenchyma next to and in the thickness of the fibrous capsule

Locations

Country	Name	City	State
Uzbekistan	Republican specialized scientific and practical medical center of surgery named after academician V.Vakhidov	Tashkent

Sponsors (1)

Lead Sponsor	Collaborator
Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov

Country where clinical trial is conducted

Uzbekistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of viable germinal elements of echinococcosis	Identification of viable germinal elements of echinococcosis according to morphological analysis	1 day
Secondary	Recurrence of liver echinococcosis	Identification of frequency of liver echinococcosis in postoperative period	1 year