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

NCT06570876 | Completed

• 1 other identifier: PR048/23
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver; Cyst, Hydatid, Granulosus (Etiology)

Keywords

Liver cystic echinococcosis; Liver hydatid; Hepatic resection; Hepatic surgery; Biliary fistula; Bile leakage; Recurrence; Risk factor

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• To estimate the incidence of overall morbidity related to surgery.

  90 days postoperative

• To estimate the incidence of specific morbidity 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 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

Study Arms (2)

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

Conservative surgery

Partial cystopericystectomy and the Lagrot technique are considered CS.

Procedure: Surgery

Interventions

Surgery 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; Radical surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Marina Vila Tura

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (8)

• 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.

  PMID: 14575976 BACKGROUND

• 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.

  PMID: 10773125 BACKGROUND

• 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.

  PMID: 17976950 BACKGROUND

• 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.

  PMID: 18387467 BACKGROUND

• 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.

  PMID: 30760475 BACKGROUND

• 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.

  PMID: 35211944 BACKGROUND

• 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.

  PMID: 34949334 BACKGROUND

• 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.

  PMID: 29170917 BACKGROUND

MeSH Terms

Conditions

Cysts; Biliary Fistula; Recurrence

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Digestive System Fistula; Digestive System Diseases; Fistula; Disease Attributes; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Marina Vila Tura, MD

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: January 1, 1996
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)