SarcopeniaSARFONCT03754452
Evaluation of the Sarcopenia in Hepatobiliary Surgery
An observational study of Sarcopenia and Hepatobiliary Disease, run by University Hospital, Angers at 1 site in France.
Trial summary
The sarcopenia is defined as a loss of muscle mass and a loss of muscle function ( strength or performance). Some studies showed that the sarcopenia increase the postoperative complications and the overall survival in abdominal surgery. But the sarcopenia is not evaluated in the Hepatobiliary surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia, Hepatobiliary Disease, Postoperative Complications
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2018to 7 Sep 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
- No healthy volunteers
- Adult, Older adult
Study population: - all patients who should have a hepatobiliary surgery for malignant and benign tumor in the universitary hospital center of Angers
Who may be able to join
- hepatobiliary surgery
- scheduled surgery
- oral consent
Who cannot join
- pregnancy
- patient under low protection
- emergency surgery
- hepatic encephalopathy stage II, III and IV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Prevalence, the Diagnosis Tests, and the Associated Morbimortality of Sarcopenia in Hepatobiliary Surgery
The sarcopenia is defined as a loss of muscle mass and a loss of muscle function ( strength or performance). Some studies showed that the sarcopenia increase the postoperative complications and the overall survival in abdominal surgery. But the sarcopenia is not evaluated in the Hepatobiliary surgery. This prospective, monconcentrique study aim to evaluate the prevalence of sarcopenia, and its associated morbimortality in hepatobiliary surgery for malignant or benign tumors.
- Medical subject headings
- Sarcopenia, Digestive System Diseases, Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of patients with a sarcopenia before having a hepatobiliary surgery mesured by impedancemetry and by the muscular force or the speed walking
for the man : i/impedancemetry BMI<8,87kg/m2 and ii/ a muscular force < 30kg or a walking speed <0,8m/s
Measured: 1 month
the number of patients with a sarcopenia before having a hepatobiliary surgery mesured by impedancemetry and by the muscular force or the speed walking
for the woman: i/impedancemetry BMI<6,42kg/m2 and ii/muscular force < 20kg or a walking speed <0,8m/s
Measured: 1 month
Secondary outcomes (2)
comparison between the impedancemetry and the abdominopevis CT for the diagnosis of sarcopenia
- impedancemetry used to evaluate the muscular mass
- abdominopelvis CT evualate the muscular mass by measuring the muscular area on the L3 section
Measured: 3 months
comparison of the postoperatives complications using the clavien dindo classsification between the patient with sarcopenia and the patient without sarcopenia.
postoperatives complications evualuated according the clavien dindo classification are : death, nausea, vomit, need of nasogastric tube, liver failure with jaundice, ascites, liver encephalopathy, biliary fistula, biliary peritonitis, hernia, parietal abcess, urinary infection, urinary retention, hematoma, pulmonary embolism, pulmonary infection, pleural effusion, atelectasis, renal failure, hyponatremia, hypernatremia, hypokaliema, hyperkaliema the post operative complication evaluate
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start9 Nov 2018
- Primary completion7 Sep 2021
- Study completion7 Sep 2021
Why it stopped: No inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Julien BARBIEUX, Dr, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754452
- Sponsor's protocol ID
- 2018-A1104-51
- Acronym
- SARFO
- Status last verified
- Jan 2024
- First submitted
- 12 Nov 2018
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevalence, the Diagnosis Tests, and the Associated Morbimortality of Sarcopenia in Hepatobiliary Surgery
- ClinicalTrials.gov ID
- NCT03754452
- Acronym / sponsor ID
- SARFO / 2018-A1104-51
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No inclusion
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 7 Sep 2021 (actual)
- Study completion
- 7 Sep 2021 (actual)
- First posted
- 27 Nov 2018 (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 sarcopenia is defined as a loss of muscle mass and a loss of muscle function ( strength or performance). Some studies showed that the sarcopenia increase the postoperative complications and the overall survival in abdominal surgery. But the sarcopenia is not evaluated in the Hepatobiliary surgery. This prospective, monconcentrique study aim to evaluate the prevalence of sarcopenia, and its associated morbimortality in hepatobiliary surgery for malignant or benign tumors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - all patients who should have a hepatobiliary surgery for malignant and benign tumor in the universitary hospital center of Angers
Key inclusion criteria (3 listed)
- hepatobiliary surgery
- scheduled surgery
- oral consent
Key exclusion criteria (4 listed)
- pregnancy
- patient under low protection
- emergency surgery
- hepatic encephalopathy stage II, III and IV
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
the number of patients with a sarcopenia before having a hepatobiliary surgery mesured by impedancemetry and by the muscular force or the speed walking
Time frame: 1 month
for the man : i/impedancemetry BMI<8,87kg/m2 and ii/ a muscular force < 30kg or a walking speed <0,8m/s
the number of patients with a sarcopenia before having a hepatobiliary surgery mesured by impedancemetry and by the muscular force or the speed walking
Time frame: 1 month
for the woman: i/impedancemetry BMI<6,42kg/m2 and ii/muscular force < 20kg or a walking speed <0,8m/s
2 secondary outcomes
comparison between the impedancemetry and the abdominopevis CT for the diagnosis of sarcopenia
Time frame: 3 months
comparison of the postoperatives complications using the clavien dindo classsification between the patient with sarcopenia and the patient without sarcopenia.
Time frame: 4 months
Results and safety
The study was stopped early (reason given: No inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Julien BARBIEUX, Dr principal investigator
University Hospital, Angers
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 Sarcopenia and Hepatobiliary Disease, run by University Hospital, Angers 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 4 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: stopped early, as of the sponsor's last update on 11 Jan 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?
The study was stopped early (reason given: No inclusion). Results are not available in the source record.
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?
the number of patients with a sarcopenia before having a hepatobiliary surgery mesured by impedancemetry and by the muscular force or the speed walking (time frame: 1 month). 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?
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 11 Jan 2024.