NCT06570876

Radical Versus Conservative Surgery in Liver Cystic Echinococcosis: a Prospective Cohort Study in a High-volume Western Centre

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 192 (actual)
• Sponsor: Hospital Universitari de Bellvitge · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The goal of this observational study is to compare the results in terms of morbidity and disease-free survival between groups of patients with liver cystic echinococcosis (LCE) managed with radical surgery (RS) or conservative surgery (CS), and to evaluate potential risk factors of clinically relevant biliary fistula and liver recurrence.

Detailed description

Main hypothesis: 1. Radical surgery (RS) in LCE has better postoperative results than conservative surgery (CS) in terms of global morbidity, specific morbidity and liver recurrence rate. Secondary hypotheses: 2. It is possible to identify preoperative and intraoperative prognostic factors of higher morbidity and recurrence rate. 3. The location of the residual pericystic layer in CS is related to a higher incidence of liver recurrence. 4. The percentage of residual pericystic layer in CS is related to a higher incidence of postoperative biliary fistula. Main outcome: 1. To assess the incidence of liver recurrence between the RS and the CS groups, identifying potential risk factors. 2. To evaluate the incidence of postoperative biliary fistula between the RS and the CS groups, identifying possible risk factors. Secondary outcomes: 1. To estimate the incidence of overall morbidity related to surgery. 2. To estimate the incidence of specific morbidity related to surgery (biliary fistula, intra-abdominal abscess, residual cavity abscess, hemoperitoneum, incisional infection, liver failure, respiratory infection, others). 3. To specifically analyze the incidence of postoperative biliary fistula and complex biliary fistula, and identify possible risk factors. 4. To estimate the incidence of mortality related to surgery. 5. To estimate the rate of hepatic and extrahepatic recurrence (number of disease-free months) 6. Prepare a recommendation for a standardized management algorithm for LCE patients based on the results obtained in the study and make it applicable to clinical practice.

Conditions

• Liver; Cyst, Hydatid, Granulosus (Etiology)

Interventions

Type	Name	Description
PROCEDURE	Surgery	The decision between RS and CS depended on the patient's performance status; on the cyst's main characteristics and contact with liver structures; and on intraoperative findings.

Timeline

• Start date: 1996-01-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2024-08-26
• Last updated: 2024-08-26

Locations

1 site across 1 country: Spain