Clinical trial NCT06570876: Radical Versus Conservative Surgery in Liver Cystic Echinococcosis: a Prospective Cohort Study in a High-volume Western Centre
Official title: Radical Versus Conservative Surgery in Liver Cystic Echinococcosis: a Prospective Cohort Study in a High-volume Western Centre
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver; Cyst, Hydatid, Granulosus (Etiology)
Keywords: Liver cystic echinococcosis
Liver hydatid
Hepatic resection
Hepatic surgery
Biliary fistula
Bile leakage
Recurrence
Risk factor
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A prospective analysis of patients who undergo surgery for LCE from January 1996 to December 2021 at the Hepatobiliary Surgery and Liver Transplantation Unit of the Bellvitge University Hospital.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To assess the incidence of liver recurrence between the RS and the CS groups, identifying potential risk factors
timeFrame: Diagnosis during the first 6 months was considered as persistence of the disease.
measure: To evaluate the incidence of postoperative biliary fistula between the RS and the CS groups, identifying possible risk factors.
timeFrame: 90 days postoperative
Secondary outcomes:
measure: To estimate the incidence of overall morbidity related to surgery.
timeFrame: 90 days postoperative
measure: To estimate the incidence of specific morbidity related to surgery.
timeFrame: 90 days postoperative
measure: To specifically analyze the incidence of postoperative biliary fistula and complex biliary fistula, and identify possible risk factors.
timeFrame: 90 days postoperative
measure: To estimate the incidence of mortality related to surgery.
timeFrame: 90 days postoperative
measure: To estimate the rate of hepatic and extrahepatic recurrence (number of disease-free months)
timeFrame: From 6 months postoperative
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Marina Vila Tura
state: Barcelona
Study officials:
References:
citation: McManus DP, Zhang W, Li J, Bartley PB. Echinococcosis. Lancet. 2003 Oct 18;362(9392):1295-304. doi: 10.1016/S0140-6736(03)14573-4.
citation: Gollackner B, Langle F, Auer H, Maier A, Mittlbock M, Agstner I, Karner J, Langer F, Aspock H, Loidolt H, Rockenschaub S, Steininger R. Radical surgical therapy of abdominal cystic hydatid disease: factors of recurrence. World J Surg. 2000 Jun;24(6):717-21. doi: 10.1007/s002689910115.
citation: Beyrouti MI, Beyrouti R, Bouassida M, Ben Amar M, Frikha F, Ben Salah K, Abid B, Guirat A, Ghorbel A, Mnif J, Ayadi A. [Hydatid cysts of the spigelian lobe (segment I) of the liver: clinical and therapeutic particularities]. Presse Med. 2007 Dec;36(12 Pt 1):1732-7. doi: 10.1016/j.lpm.2007.03.047. Epub 2007 Oct 31. French.
citation: El Malki HO, El Mejdoubi Y, Souadka A, Mohsine R, Ifrine L, Abouqal R, Belkouchi A. Predictive factors of deep abdominal complications after operation for hydatid cyst of the liver: 15 years of experience with 672 patients. J Am Coll Surg. 2008 Apr;206(4):629-37. doi: 10.1016/j.jamcollsurg.2007.11.012. Epub 2008 Jan 28.
citation: Wen H, Vuitton L, Tuxun T, Li J, Vuitton DA, Zhang W, McManus DP. Echinococcosis: Advances in the 21st Century. Clin Microbiol Rev. 2019 Feb 13;32(2):e00075-18. doi: 10.1128/CMR.00075-18. Print 2019 Mar 20.
citation: Kratzer W, Weimer H, Schmidberger J. Echinococcosis: a Challenge for Liver Sonography. Ultraschall Med. 2022 Apr;43(2):120-145. doi: 10.1055/a-1694-5552. Epub 2022 Feb 24.
citation: Farhat W, Ammar H, Rguez A, Harrabi F, Said MA, Ghabry L, Gupta R, Ben Cheikh A, Ghali H, Ben Rajeb M, Ben Mabrouk M, Ben Ali A. Radical versus conservative surgical treatment of liver hydatid cysts: A paired comparison analysis. Am J Surg. 2022 Jul;224(1 Pt A):190-195. doi: 10.1016/j.amjsurg.2021.12.014. Epub 2021 Dec 16.
citation: Pang Q, Jin H, Man Z, Wang Y, Yang S, Li Z, Lu Y, Liu H, Zhou L. Radical versus conservative surgical treatment of liver hydatid cysts: a meta-analysis. Front Med. 2018 Jun;12(3):350-359. doi: 10.1007/s11684-017-0559-y. Epub 2017 Nov 23.