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

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.

Study Overview

• Status: Completed
• Conditions: Liver; Cyst, Hydatid, Granulosus (Etiology)
• Intervention / Treatment: Procedure: Surgery

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 Type: Observational
• Enrollment (Actual): 192

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Marina Vila Tura

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Procedure: 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.
Conservative surgery; Partial cystopericystectomy and the Lagrot technique are considered CS.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the incidence of liver recurrence between the RS and the CS groups, identifying potential risk factors	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.	Diagnosis during the first 6 months was considered as persistence of the disease.
To evaluate the incidence of postoperative biliary fistula between the RS and the CS groups, identifying possible risk factors.	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.	90 days postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To estimate the incidence of overall morbidity related to surgery.		90 days postoperative
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).	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 mortality related to surgery.		90 days postoperative
To estimate the rate of hepatic and extrahepatic recurrence (number of disease-free months)		From 6 months postoperative

Collaborators and Investigators

• Sponsor: Hospital Universitari de Bellvitge

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Ultraschall Med. 2022 Apr;43(2):e11. doi: 10.1055/a-1787-6986.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 1996
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Recurrence; Hepatic resection; Risk factor; Hepatic surgery; Biliary fistula; Liver cystic echinococcosis; Liver hydatid; Bile leakage
• Additional Relevant MeSH Terms: Infections; Parasitic Diseases; Helminthiasis; Cestode Infections; Echinococcosis
• Other Study ID Numbers: PR048/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No