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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

192 participants

Study Classification

OBSERVATIONAL

Study Start Date

1996-01-01

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Surgical Treatment of Hepatic Hydatidosis in Elderly Patients

NCT05113550

Cystic Echinococcosis

COMPLETED

Radical Versus Conservative Surgical Treatment of Liver Hydatid Cysts

NCT04988958

Hydatid Cyst

COMPLETED

Surgical Treatment of Liver Hydatid Cyst (SURGHIDA)

NCT05420155

Echinococcosis, Hepatic

COMPLETED

Contrast Enhanced Ultrasound and Molecular Analysis in the Diagnosis of Pancreatic Cyst

NCT03740360

Pancreatic Cyst

COMPLETED

The Current Study Aimed to Evaluate the Therapeutic Features and Complications of Liver Hydatid Cyst in Patients Who Underwent Surgery for CE in Fars Province, Southern Iran.

NCT04363151

Patients Who Underwent Surgury for Hydatid Cyst

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Liver; Cyst, Hydatid, Granulosus (Etiology)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Radical 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).

Surgery

Intervention Type PROCEDURE

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.

Conservative surgery

Partial cystopericystectomy and the Lagrot technique are considered CS.

Surgery

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No