Liver CancerMILSOBESNCT05475054
Impact of Minimally Invasive and Open Liver Surgery in Different BMI-classes
An observational study of Liver Cancer and Liver Metastases, run by Fondazione Poliambulanza Istituto Ospedaliero at 1 site in Italy.
Trial summary
Despite the worldwide increase of both obesity and use of minimally invasive liver surgery(MILS), evidence regarding the safety and eventual benefits of MILS in obese patients is scarce. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Liver Metastases, Obesity
- What is being tested?
- Minimally invasive liver resection
- Type of treatment
- Surgery or procedure
- How many people
- 9,963 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2020to 22 Jul 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who underwent an elective liver resection at 20 hepatobiliary referral centres between January 2009 and December 2019
Who may be able to join
- Patients aged 18 years and older
- Patients that have undergone an elective minimally invasive or open liver resection
Who cannot join
- Patients that have undergone a hand-assisted or robotic procedure
- Patients with a BMI lower than 18.5
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Indications, Trends, and Perioperative Outcomes of Minimally Invasive and Open Liver Surgery in Non-obese and Obese Patients: an International Multicentre Propensity Score Matched Retrospective Cohort Study of 9963 Patients.
Despite the worldwide increase of both obesity and use of minimally invasive liver surgery(MILS), evidence regarding the safety and eventual benefits of MILS in obese patients is scarce. The aim of this study is therefore to compare the outcomes of non-obese and obese patients(BMI 18.5-29.9 and BMI≥30, respectively) undergoing MILS and OLS, and to assess trends in MILS use among obese patients. In this retrospective cohort study, patients operated at 20 hospitals in eight countries(2009-2019) will be included and the characteristics and outcomes of non-obese and obese patients will be compared. Thereafter, the outcomes of MILS and OLS were compared in both groups after propensity-score matching(PSM). Changes in the adoption of MILS during the study period will be investigated.
- Conditions
- Liver Cancer, Liver Metastases, Obesity
- Being tested
- Minimally invasive liver resection
- Keywords
- overweight, fatty liver, open liver resection, laparoscopic liver resection, minimally invasive liver resection
- Medical subject headings
- Liver Neoplasms, Obesity, Overweight, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive liver resectionProcedure or surgery
Also called Laparoscopic liver resection
A liver resection performed by minimally invasive (keyhole) surgery
| Study group | Role | What they receive |
|---|---|---|
| Open liver resection | Non-obese or obese patients that underwent an open liver resection for all indications | |
| Minimally invasive liver resection | Non-obese or obese patients that underwent a minimally invasive liver resection for all indications Receives: Procedure: Minimally invasive liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major complications
Severe complications (Clavien-Dindo grade 3a or higher) related to the surgical procedure
Measured: 30 days postoperatively
Secondary outcomes (13)
Overall complications
Overall complications related to the surgical procedure
Measured: 30 days postoperatively
Length of hospital stay
The length of hospital stay for the surgical procedure
Measured: 30 days postoperatively
R0 resection margin
Proportion of patients in whom a microscopically radical resection of both the primary colorectal carcinoma and the liver metastases was performed.
Proportion of patients in whom a microscopically radical resection was performed
Measured: 30 days postoperatively
Intraoperative blood loss
Intraoperative blood loss in milliliters
Measured: During the surgical procedure
Operative time
Operative time in minutes
Measured: During the surgical procedure
Conversion to open surgery
Intra-operative conversion to an open or hand-assisted procedure in the minimally invasive group
Measured: During the surgical procedure
Respiratory complications
All respiratory complications
Measured: 30 days postoperatively
Wound-related complications
All wound-related complications
Measured: 30 days postoperatively
Post-hepatectomy liver failure
Occurrence of post-hepatectomy liver failure (ISGLS definition and classification)
Measured: 30 days postoperatively
Bile leak
Occurrence of bile leak (ISGLS definition and classification)
Measured: 30 days postoperatively
Ascites
Occurrence of ascites
Measured: 30 days postoperatively
Mortality
Postoperative mortality
Measured: 90 days postoperatively
Red blood cell transfusion
Intraoperative red blood cell transfusion
Measured: During the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Dec 2020
- Primary completion18 Jul 2022
- Study completion22 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies 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
- Retrospective
- Enrolment
- 9,963 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Poliambulanza Istituto Ospedaliero
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), The Queen Elizabeth Hospital, Umberto I Mauriziano Hospital, Turin, Italy, Oslo University Hospital and Institute of Medicine, University of Oslo, Oslo, Norway, Padua University Hospital, Padua, Italy, IRCCS San Raffaele, University Hospital of Girona Dr. Josep Trueta, Clinica Universidad de Navarra, Universidad de Navarra, Institut Mutualiste Montsouris, Université Paris Descartes, Paris, France, Groeninge Hospital, Kortrijk, Belgium, University Hospital Southampton NHS Foundation Trust, Riuniti Hospital, Polytechnic University of Marche, Ancona, Italy, Universita di Verona, Virginia Mason Medical Center, Seattle, USA, University of California, San Francisco, Moscow Clinical Research Centre, Moscow, Russia, Catholic University of the Sacred Heart, Antoine Béclère Hospital, Paris, France, IRCCS Azienda Ospedaliero-Universitaria di Bologna, University of Modena and Reggio Emilia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475054
- Sponsor's protocol ID
- NP5469
- Acronym
- MILSOBES
- Status last verified
- Feb 2023
- First submitted
- 22 Jul 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data of this study will be available from the corresponding author, Professor Mohammed Abu Hilal, upon reasonable request. The data are not publicly available since this could compromise the privacy of research participants.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indications, Trends, and Perioperative Outcomes of Minimally Invasive and Open Liver Surgery in Non-obese and Obese Patients: an International Multicentre Propensity Score Matched Retrospective Cohort Study of 9963 Patients.
- ClinicalTrials.gov ID
- NCT05475054
- Acronym / sponsor ID
- MILSOBES / NP5469
- Conditions
- Liver Cancer, Liver Metastases, Obesity
- Keywords
- overweight, fatty liver, open liver resection, laparoscopic liver resection, minimally invasive liver resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,963 participants (actual)
- Lead sponsor
- Fondazione Poliambulanza Istituto OspedalieroUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), The Queen Elizabeth Hospital, Umberto I Mauriziano Hospital, Turin, Italy, Oslo University Hospital and Institute of Medicine, University of Oslo, Oslo, Norway, Padua University Hospital, Padua, Italy, IRCCS San Raffaele, University Hospital of Girona Dr. Josep Trueta, Clinica Universidad de Navarra, Universidad de Navarra, Institut Mutualiste Montsouris, Université Paris Descartes, Paris, France, Groeninge Hospital, Kortrijk, Belgium, University Hospital Southampton NHS Foundation Trust, Riuniti Hospital, Polytechnic University of Marche, Ancona, Italy, Universita di Verona, Virginia Mason Medical Center, Seattle, USA, University of California, San Francisco, Moscow Clinical Research Centre, Moscow, Russia, Catholic University of the Sacred Heart, Antoine Béclère Hospital, Paris, France, IRCCS Azienda Ospedaliero-Universitaria di Bologna, University of Modena and Reggio Emilia
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 26 Jul 2022 (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.
Despite the worldwide increase of both obesity and use of minimally invasive liver surgery(MILS), evidence regarding the safety and eventual benefits of MILS in obese patients is scarce. The aim of this study is therefore to compare the outcomes of non-obese and obese patients(BMI 18.5-29.9 and BMI≥30, respectively) undergoing MILS and OLS, and to assess trends in MILS use among obese patients. In this retrospective cohort study, patients operated at 20 hospitals in eight countries(2009-2019) will be included and the characteristics and outcomes of non-obese and obese patients will be compared. Thereafter, the outcomes of MILS and OLS were compared in both groups after propensity-score matching(PSM). Changes in the adoption of MILS during the study period will be investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open liver resection | – | –Non-obese or obese patients that underwent an open liver resection for all indications |
| Minimally invasive liver resection | – | Procedure: Minimally invasive liver resectionNon-obese or obese patients that underwent a minimally invasive liver resection for all indications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who underwent an elective liver resection at 20 hepatobiliary referral centres between January 2009 and December 2019
Key inclusion criteria (2 listed)
- Patients aged 18 years and older
- Patients that have undergone an elective minimally invasive or open liver resection
Key exclusion criteria (2 listed)
- Patients that have undergone a hand-assisted or robotic procedure
- Patients with a BMI lower than 18.5
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 |
|---|---|---|
| Minimally invasive liver resectionAlso: Laparoscopic liver resectionA liver resection performed by minimally invasive (keyhole) surgery | Procedure or surgery | Minimally invasive liver resection |
Primary outcome
Major complications
Time frame: 30 days postoperatively
Severe complications (Clavien-Dindo grade 3a or higher) related to the surgical procedure
13 secondary outcomes
Overall complications
Time frame: 30 days postoperatively
Length of hospital stay
Time frame: 30 days postoperatively
R0 resection margin
Time frame: 30 days postoperatively
Intraoperative blood loss
Time frame: During the surgical procedure
Operative time
Time frame: During the surgical procedure
Conversion to open surgery
Time frame: During the surgical procedure
Respiratory complications
Time frame: 30 days postoperatively
Wound-related complications
Time frame: 30 days postoperatively
Post-hepatectomy liver failure
Time frame: 30 days postoperatively
Bile leak
Time frame: 30 days postoperatively
Ascites
Time frame: 30 days postoperatively
Mortality
Time frame: 90 days postoperatively
Red blood cell transfusion
Time frame: During the surgical procedure
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 15 Feb 2023.
- Individual participant dataSharing planned: Undecided. The data of this study will be available from the corresponding author, Professor Mohammed Abu Hilal, upon reasonable request. The data are not publicly available since this could compromise the privacy of research participants.
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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 Cancer and Liver Metastases, run by Fondazione Poliambulanza Istituto Ospedaliero at 1 site in Italy.
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 2 inclusion and 2 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 15 Feb 2023. 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 Italy. 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?
Major complications (time frame: 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2023.