Liver; Cyst, Hydatid, Granulosus (Etiology)
Conditions
Keywords
Liver cystic echinococcosis, Liver hydatid, Hepatic resection, Hepatic surgery, Biliary fistula, Bile leakage, Recurrence, Risk factor
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.
Interventions
PROCEDURESurgery
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.
Sponsors
Hospital Universitari de Bellvitge
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| To estimate the incidence of overall morbidity related to surgery. | 90 days postoperative | — |
| To estimate the incidence of mortality related to surgery. | 90 days postoperative | — |
| 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 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 rate of hepatic and extrahepatic recurrence (number of disease-free months) | From 6 months postoperative | — |
Countries
Spain
Outcome results
None listed