Liver DiseasesHMCVNCT06501742
Major Hepatectomy and Vascular Clamping
An observational study of Liver Diseases, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
A major hepatectomy consists of the resection of 3 or more liver segments. Its indications are mainly secondary malignant lesions, then primary malignant lesions, benign lesions and septic resections. Around a hundred major hepatectomies are carried out every year in Strasbourg. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jan 2024to 31 Dec 2025
- 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: Major subject (≥ 18 years old) operated on for a major hepatectomy at Strasbourg University Hospital during the period from January 1, 2023 to December 31/2023
Who may be able to join
- Major subject (≥ 18 years old)
- Subject operated on for a major hepatectomy at Strasbourg University Hospital during the period from January 1, 2023 to December 31/2023
- Subject who has not expressed opposition to the reuse of their data for scientific research purposes.
Who cannot join
- Subject having expressed opposition to participating in the study
- History of liver resection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'Anesthésie - Réanimation Chirurgicale - CHU de Strasbourg - France
Strasbourg, 67091
Benjamin LEBAS, MD, 33.3.88.12.70.96, Benjamin.lebas@chru-strasbourg.fr
Benjamin LEBAS, MD
About this study
Official title: Major Hepatectomy and Vascular Clamping: Pre- and Intra-operative Predictive Factors of Vascular Clamping, Intra- and Post-operative Tolerance
A major hepatectomy consists of the resection of 3 or more liver segments. Its indications are mainly secondary malignant lesions, then primary malignant lesions, benign lesions and septic resections. Around a hundred major hepatectomies are carried out every year in Strasbourg. This surgery is burdened by 4.5% mortality at day 90 and 20 to 50% morbidity. The main intraoperative risks are hemorrhage and hemodynamic instability. Surgical vascular clamping helps reduce the risk of bleeding but is responsible for sometimes major hemodynamic variations, ischemia-reperfusion syndromes and can lead to acute post-operative liver failure. Recent literature attests to the safety of liver resection without vascular clamping, which is why it is less and less practiced.
Different elements are identified as independent risk factors for morbidity and mortality: the presence of cirrhosis, portal embolization, history of renal or cardiac failure, duration of vascular clamping, resected liver volume, transfusion of products labile blood and associated surgical procedures.
Given the significant risk of intra- and post-operative complications, it seems relevant to analyze pre- and intra-operative data in order to highlight risk factors for vascular clamping. This would allow better anticipation of complications, patient information, adaptation of intraoperative monitoring and postoperative surveillance and perhaps a reduction in complications. This study also makes it possible to take stock of the epidemiology around hepatectomies performed at the STRASBOURG University Hospital.
- Conditions
- Liver Diseases
- Keywords
- Liver Diseases, Hepatectomy, Liver Cancer
- Medical subject headings
- Liver Diseases, Liver Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyze pre- and intra-operative data from a major hepatectomy in order to identify possible predictive factors for intra-operative vascular clamping.
Quantitative variables are described using the usual position and dispersion statistics, namely mean, median, minimum, maximum, standard deviation and quantile. The qualitative variables are described with the numbers (in number) and proportions (in %)of each modality.
The Chi2 test will be used to study the crossover between
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start24 Jan 2024
- Primary completionDec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501742
- Sponsor's protocol ID
- 9138
- Acronym
- HMCV
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Major Hepatectomy and Vascular Clamping: Pre- and Intra-operative Predictive Factors of Vascular Clamping, Intra- and Post-operative Tolerance
- ClinicalTrials.gov ID
- NCT06501742
- Acronym / sponsor ID
- HMCV / 9138
- Conditions
- Liver Diseases
- Keywords
- Liver Diseases, Hepatectomy, Liver Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Jul 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.
A major hepatectomy consists of the resection of 3 or more liver segments. Its indications are mainly secondary malignant lesions, then primary malignant lesions, benign lesions and septic resections. Around a hundred major hepatectomies are carried out every year in Strasbourg. This surgery is burdened by 4.5% mortality at day 90 and 20 to 50% morbidity. The main intraoperative risks are hemorrhage and hemodynamic instability. Surgical vascular clamping helps reduce the risk of bleeding but is responsible for sometimes major hemodynamic variations, ischemia-reperfusion syndromes and can lead to acute post-operative liver failure. Recent literature attests to the safety of liver resection without vascular clamping, which is why it is less and less practiced.
Different elements are identified as independent risk factors for morbidity and mortality: the presence of cirrhosis, portal embolization, history of renal or cardiac failure, duration of vascular clamping, resected liver volume, transfusion of products labile blood and associated surgical procedures.
Given the significant risk of intra- and post-operative complications, it seems relevant to analyze pre- and intra-operative data in order to highlight risk factors for vascular clamping. This would allow better anticipation of complications, patient information, adaptation of intraoperative monitoring and postoperative surveillance and perhaps a reduction in complications. This study also makes it possible to take stock of the epidemiology around hepatectomies performed at the STRASBOURG University Hospital.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major subject (≥ 18 years old) operated on for a major hepatectomy at Strasbourg University Hospital during the period from January 1, 2023 to December 31/2023
Key inclusion criteria (3 listed)
- Major subject (≥ 18 years old)
- Subject operated on for a major hepatectomy at Strasbourg University Hospital during the period from January 1, 2023 to December 31/2023
- Subject who has not expressed opposition to the reuse of their data for scientific research purposes.
Key exclusion criteria (2 listed)
- Subject having expressed opposition to participating in the study
- History of liver resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Analyze pre- and intra-operative data from a major hepatectomy in order to identify possible predictive factors for intra-operative vascular clamping.
Time frame: Up to 1 year
Quantitative variables are described using the usual position and dispersion statistics, namely mean, median, minimum, maximum, standard deviation and quantile. The qualitative variables are described with the numbers (in number) and proportions (in %)of each modality. The Chi2 test will be used to study the crossover between
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
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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.
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 Diseases, run by University Hospital, Strasbourg, France at 1 site in France.
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 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: status not confirmed, as of the sponsor's last update on 15 Jul 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin LEBAS, MD (: 33.3.88.12.70.96, Benjamin.lebas@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyze pre- and intra-operative data from a major hepatectomy in order to identify possible predictive factors for intra-operative vascular clamping. (time frame: Up to 1 year). 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 Jul 2024.