Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570876
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Radical Versus Conservative Surgery in Liver Cystic Echinococcosis a Prospective Cohort Study in a High-volume Western Centre
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Radical Versus Conservative Surgery in Liver Cystic Echinococcosis a Prospective Cohort Study in a High-volume Western Centre
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None