Liver DysfunctionDEBIFOIENCT03371537
Study of Hemodynamic Conditions Measured During Hepatectomy
An observational study of Liver Dysfunction and Circulatory; Change, run by University Hospital, Tours at 1 site in France.
Trial summary
Hepatocellular insufficiency is a dreaded complication after hepatectomy, since, if it is persistent, it leads to the death of the patient in the absence of liver transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Dysfunction, Circulatory; Change
- What is being tested?
- Liver debit measure
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 8 Oct 2017to 19 Mar 2019
- 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: Patient undergoing laparotomy for liver resection
Who may be able to join
- patient 18 years or more
- Patient undergoing laparotomy for liver resection
Who cannot join
- Patient under tutorship or curatorship
- Pregnant or lactating woman
- Difficulties in understanding French
- Patient operated by laparoscopy
- Patient having objected to the processing of his data
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Chirurgie Digestive, Oncologique, Endocrinienne et Transplantation Hépatique, CHRU de TOURS
Tours, 37044
About this study
Hepatocellular insufficiency is a dreaded complication after hepatectomy, since, if it is persistent, it leads to the death of the patient in the absence of liver transplantation.
The preoperative evaluation aims in particular to estimate the risk of postoperative hepatocellular insufficiency so as to minimize or contraindicate high-risk patients.
Read more
It has been shown that the flow of the portal vein is correlated with liver function, especially in the living donor and after portal embolization. More recently, the study of flow rates in the portal vein and the hepatic artery after transplantation has shown a correlation with the recovery of graft function.
The hypothesis is that portal and arterial flow after hepatectomy can predict postoperative hepatocellular function.
Read the detailed description
Measurements of flow rates in the portal vein and the hepatic artery by different transit times are available thanks to the Medistim VeriQTM system that the investigators already use routinely in the context of liver transplantation when performing hepatectomies.
- Conditions
- Liver Dysfunction, Circulatory; Change
- Being tested
- Liver debit measure
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver debit measureProcedure or surgery
Mesure of liver debit during hepatectomy
| Study group | Role | What they receive |
|---|---|---|
| Hepatectomy | Patient undergoing laparotomy for liver resection. The aim is to measure the flow rates in the portal vein and the hepatic artery. Receives: Procedure: Liver debit measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver vessel debit
Mesure of liver debit during hepatectomy
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start8 Oct 2017
- Primary completion19 Mar 2019
- Study completion19 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DysfunctionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ephrem SALAME, MD-PhD, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371537
- Sponsor's protocol ID
- RIPH3-RNI17/DEBIFOIE
- Other IDs
- 2017-A01754-49, 2017-61
- Acronym
- DEBIFOIE
- Status last verified
- Mar 2021
- First submitted
- 8 Dec 2017
- Last updated
- 18 Mar 2021
- 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 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Hemodynamic Conditions Measured During Hepatectomy
- ClinicalTrials.gov ID
- NCT03371537
- Acronym / sponsor ID
- DEBIFOIE / RIPH3-RNI17/DEBIFOIE
- Conditions
- Liver Dysfunction, Circulatory; Change
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 8 Oct 2017 (actual)
- Primary completion
- 19 Mar 2019 (actual)
- Study completion
- 19 Mar 2019 (actual)
- First posted
- 13 Dec 2017 (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.
Hepatocellular insufficiency is a dreaded complication after hepatectomy, since, if it is persistent, it leads to the death of the patient in the absence of liver transplantation.
The preoperative evaluation aims in particular to estimate the risk of postoperative hepatocellular insufficiency so as to minimize or contraindicate high-risk patients.
It has been shown that the flow of the portal vein is correlated with liver function, especially in the living donor and after portal embolization. More recently, the study of flow rates in the portal vein and the hepatic artery after transplantation has shown a correlation with the recovery of graft function.
The hypothesis is that portal and arterial flow after hepatectomy can predict postoperative hepatocellular function.
Detailed description
Measurements of flow rates in the portal vein and the hepatic artery by different transit times are available thanks to the Medistim VeriQTM system that the investigators already use routinely in the context of liver transplantation when performing hepatectomies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatectomy | – | Procedure: Liver debit measurePatient undergoing laparotomy for liver resection. The aim is to measure the flow rates in the portal vein and the hepatic artery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient undergoing laparotomy for liver resection
Key inclusion criteria (2 listed)
- patient 18 years or more
- Patient undergoing laparotomy for liver resection
Key exclusion criteria (5 listed)
- Patient under tutorship or curatorship
- Pregnant or lactating woman
- Difficulties in understanding French
- Patient operated by laparoscopy
- Patient having objected to the processing of his data
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 |
|---|---|---|
| Liver debit measureMesure of liver debit during hepatectomy | Procedure or surgery | Hepatectomy |
Primary outcome
Liver vessel debit
Time frame: Baseline
Mesure of liver debit during hepatectomy
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 18 Mar 2021.
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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.
Ephrem SALAME, MD-PhD principal investigator
University Hospital, Tours
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 Dysfunction and Circulatory; Change, run by University Hospital, Tours 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 2 inclusion and 5 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 18 Mar 2021. 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 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?
Liver vessel debit (time frame: Baseline). 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 18 Mar 2021.