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

Completed

• Conditions: Liver; Cyst, Hydatid, Granulosus (Etiology)
• Interventions: Procedure: Surgery

• Registration Number: NCT06570876
• Lead Sponsor: Hospital Universitari de Bellvitge

Brief 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.

Study Timeline

• Study Start: 1996-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2024-08
• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-22
• Last Update Submitted: 2024-08-22
• Study First Posted: 2024-08-26
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

• Adult population (18 years or older) of both sexes surgically intervened for a diagnosis of LCE at the Bellvitge University Hospital and during the period described using a conservative or radical technique.
• Patients with asymptomatic liver hydatid cysts of active type or transition CE1 to CE3 according to the WHO classification.
• Patients with symptomatic or complicated hepatic hydatid cysts of any type (CE1 to CE5) according to the WHO classification.

Exclusion Criteria

• Patients under 18 years of age.
• Patient operated on for LCE diagnosis with inactive asymptomatic cysts (CE4 or CE5 according to the WHO classification).
• Patients with less than 1 year of follow-up.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conservative surgery	Surgery	Partial cystopericystectomy and the Lagrot technique are considered CS.
Radical surgery	Surgery	Total cystopericystectomy and anatomical liver resections are considered RS (i.e., segmentectomy, bisegmentectomy, left lateral segmentectomy, left hepatectomy, right hepatectomy, right trisectionectomy, and liver transplantation).

Primary Outcome Measures

Name	Time	Method
To assess the incidence of liver recurrence between the RS and the CS groups, identifying potential risk factors	Diagnosis during the first 6 months was considered as persistence of the disease.	Hepatic recurrence was defined as the appearance of a new growing cyst, non-detected by radiologic exploration before the first surgery, in the first location of the hydatid cyst in the liver or in another liver's segment.
To evaluate the incidence of postoperative biliary fistula between the RS and the CS groups, identifying possible risk factors.	90 days postoperative	The type of fistula was classified according to the International Study Group of Liver Surgery classification. A complex biliary fistula was defined as external bile leakage for ≥28 days and/or the need for percutaneous drainage or reoperation.

Secondary Outcome Measures

Name	Time	Method
To specifically analyze the incidence of postoperative biliary fistula and complex biliary fistula, and identify possible risk factors.	90 days postoperative
To estimate the incidence of overall morbidity related to surgery.	90 days postoperative
To estimate the rate of hepatic and extrahepatic recurrence (number of disease-free months)	From 6 months postoperative
To estimate the incidence of specific morbidity related to surgery.	90 days postoperative	Biliary fistula, intra-abdominal abscess, residual cavity abscess, hemoperitoneum, incisional infection, liver failure, respiratory infection, others).
To estimate the incidence of mortality related to surgery.	90 days postoperative

Trial Locations

Locations (1)

Marina Vila Tura; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain