Liver; Cyst, Hydatid, Granulosus (Etiology)NCT06570876
Radical Versus Conservative Surgery in Liver Cystic Echinococcosis: a Prospective Cohort Study in a High-volume Western Centre
An observational study of Liver; Cyst, Hydatid, Granulosus (Etiology), run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver; Cyst, Hydatid, Granulosus (Etiology)
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 192 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 1996to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Being tested
- Surgery
- Keywords
- Liver cystic echinococcosis, Liver hydatid, Hepatic resection, Hepatic surgery, Biliary fistula, Bile leakage, Recurrence, Risk factor
- Medical subject headings
- Cysts, Biliary Fistula, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Surgery | |
| Conservative surgery | Partial cystopericystectomy and the Lagrot technique are considered CS. Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 90 days postoperative
Secondary outcomes (5)
To estimate the incidence of overall morbidity related to surgery.
Measured: 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).
Measured: 90 days postoperative
To specifically analyze the incidence of postoperative biliary fistula and complex biliary fistula, and identify possible risk factors.
Measured: 90 days postoperative
To estimate the incidence of mortality related to surgery.
Measured: 90 days postoperative
To estimate the rate of hepatic and extrahepatic recurrence (number of disease-free months)
Measured: From 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 Jan 1996
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Liver; Cyst, Hydatid, Granulosus (Etiology)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Vila Tura, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570876
- Sponsor's protocol ID
- PR048/23
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 14575976Gollackner 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.
PubMed 10773125Beyrouti 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.
PubMed 17976950El 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.
PubMed 18387467Wen 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.
PubMed 30760475Kratzer 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.
PubMed 35211944Farhat 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.
PubMed 34949334Pang 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.
PubMed 29170917
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radical Versus Conservative Surgery in Liver Cystic Echinococcosis: a Prospective Cohort Study in a High-volume Western Centre
- ClinicalTrials.gov ID
- NCT06570876
- Acronym / sponsor ID
- PR048/23
- Keywords
- Liver cystic echinococcosis, Liver hydatid, Hepatic resection, Hepatic surgery, Biliary fistula, Bile leakage, Recurrence, Risk factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 1 Jan 1996 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radical surgery | – | Procedure: SurgeryTotal cystopericystectomy and anatomical liver resections are considered RS (i.e., segmentectomy, bisegmentectomy, left lateral segmentectomy, left hepatectomy, right hepatectomy, right trisectionectomy, and liver transplantation). |
| Conservative surgery | – | Procedure: SurgeryPartial cystopericystectomy and the Lagrot technique are considered CS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryThe 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. | Procedure or surgery | Conservative surgery, Radical surgery |
Primary outcome
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.
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.
5 secondary outcomes
To estimate the incidence of overall morbidity related to surgery.
Time frame: 90 days postoperative
To estimate the incidence of specific morbidity related to surgery.
Time frame: 90 days postoperative
To specifically analyze the incidence of postoperative biliary fistula and complex biliary fistula, and identify possible risk factors.
Time frame: 90 days postoperative
To estimate the incidence of mortality related to surgery.
Time frame: 90 days postoperative
To estimate the rate of hepatic and extrahepatic recurrence (number of disease-free months)
Time frame: From 6 months postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Background: PubMed 14575976McManus DP, Zhang W, Li J, Bartley PB. Echinococcosis. Lancet. 2003 Oct 18;362(9392):1295-304. doi: 10.1016/S0140-6736(03)14573-4.
- Background: PubMed 10773125Gollackner 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.
- Background: PubMed 17976950Beyrouti 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.
- Background: PubMed 18387467El 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.
- Background: PubMed 30760475Wen 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.
- Background: PubMed 35211944Kratzer 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.
- Background: PubMed 34949334Farhat 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.
- Background: PubMed 29170917Pang 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver; Cyst, Hydatid, Granulosus (Etiology), run by Hospital Universitari de Bellvitge at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06570876, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.