Skip to main content
OpenTrials
Completed

NCT Number: NCT06570876

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Liver; Cyst, Hydatid, Granulosus (Etiology) Biliary Fistula Cysts Digestive System Diseases Digestive System Fistula Disease Attributes Fistula Neoplasms Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Marina Vila Tura

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

About this study

Main hypothesis:

  • 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:

  • It is possible to identify preoperative and intraoperative prognostic factors of higher morbidity and recurrence rate.
  • The location of the residual pericystic layer in CS is related to a higher incidence of liver recurrence.
  • The percentage of residual pericystic layer in CS is related to a higher incidence of postoperative biliary fistula.

Main outcome:

  • To assess the incidence of liver recurrence between the RS and the CS groups, identifying potential risk factors.
  • To evaluate the incidence of postoperative biliary fistula between the RS and the CS groups, identifying possible risk factors.

Secondary outcomes:

  • To estimate the incidence of overall morbidity related to surgery.
  • 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).
  • To specifically analyze the incidence of postoperative biliary fistula and complex biliary fistula, and identify possible risk factors.
  • To estimate the incidence of mortality related to surgery.
  • To estimate the rate of hepatic and extrahepatic recurrence (number of disease-free months)
  • 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. To assess the incidence of liver recurrence between the RS and the CS groups, identifying potential risk factors

    Time frame: 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.

  2. To evaluate the incidence of postoperative biliary fistula between the RS and the CS groups, identifying possible risk factors.

    Time frame: 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 outcomes

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

    Time frame: 90 days postoperative

  2. To estimate the incidence of specific morbidity related to surgery.

    Time frame: 90 days postoperative

    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.

    Time frame: 90 days postoperative

  4. To estimate the incidence of mortality related to surgery.

    Time frame: 90 days postoperative

  5. To estimate the rate of hepatic and extrahepatic recurrence (number of disease-free months)

    Time frame: From 6 months postoperative

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Registry information

Important dates

Study start
1996
Primary completion
2021
Study completion
2021
First posted
Aug 26, 2024
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.