Liver DiseasesHEPATOPROTECTNCT04181502
Ischemic Preconditioning at a Distance in Liver Surgery
A study testing pneumatic tourniquet and No inflation in people with Liver Diseases, run by University Hospital, Lille at 1 site in France.
Trial summary
During hepatic transection, it exists a high risk of perioperative blood loss. The haemorrhage and its consequences (hypovolemia and blood transfusion) might impact the short and long term morbidity The vascular control by hepatic pedicle clamping (Pringle's maneuver) or total hepatic vascular exclusion, helps… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases
- What is being tested?
- pneumatic tourniquet and No inflation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2019to 6 Jan 2020
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Scheduled carcinogenic laparoscopy or laparotomy liver resection
- Insured under the social security system
- Inclined to comply to the study protocol and its duration.
Who cannot join
- Patient under guardianship
- Pregnancy or breastfeeding
- Severe lower limb vascular disease
- Emergency surgery
- Contraindication of a treatment from the protocol
- Psychological disorder with difficulty to accede the protocol
Show all 9Show fewer
- Absence of written informed consent
- Refusal to sign the protocol
- Non-registration to the social security system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Single-blind Study of Remote Ischemic Preconditioning in Hepatectomies
During hepatic transection, it exists a high risk of perioperative blood loss. The haemorrhage and its consequences (hypovolemia and blood transfusion) might impact the short and long term morbidity The vascular control by hepatic pedicle clamping (Pringle's maneuver) or total hepatic vascular exclusion, helps minimizing blood loss and leads to a more extensive hepatic resection.
Side effects of vascular control result of ischemia-reperfusion injury (IRI) : these reperfusion lesions results of different mechanisms than those responsible for the ischemic one. IRI cause lesions and postoperative dysfunction of the remaining liver.
Read more
Among strategies to reduce the adverse effects of IRI : ischaemic preconditioning (IPC) has been described. It can be either mechanical (intermittent hepatic pedicle clamping) or pharmacological (sevoflurane inhalation).
Short intermittent vascular occlusions in a organ might produce a resistance to a longer ischaemic period. It is certainly a physiological organ adaptation to tissue hypoxemia, which has a therapeutic potential when targeted.
During liver resection, ischaemic preconditioning is realised with periods of hepatic pedicle clamping and unclamping. It decrease morbidity and mortality and prevent postoperative hepatocellular insufficiency due to clamping and IRI at day 5.
Ischaemic preconditioning may also be applied remotely. Indeed, it is shown that short ischaemic periods in a target organ can also have a protective effect on distant others. This mechanism involve three signalling pathways : neuronal , humoral and systemic pathways.
In a previous randomized study, Kanoria and al, demonstrated that the remote ischaemic preconditioning group has shown significant lower rates of serum transaminases and higher liver clearance (spectrophotometry method) than the control group.
A latest study, measuring postoperative prothrombin rates has shown improved liver recovery due to halogen agents such as sevoflurane.
- Conditions
- Liver Diseases
- Being tested
- pneumatic tourniquet, No inflation
- Keywords
- Remote ischemic preconditioning, liver resection, liver clearance.
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pneumatic tourniquetProcedure or surgery
a pneumatic tourniquet around 200 mmHg after venous chase of the lower limb, during 5 minutes then deflated. Repeated twice after general anaesthesia and prior to incision.
No inflationOther
No inflation of the pneumatic tourniquet placed on the lower limb
| Study group | Role | What they receive |
|---|---|---|
| Inflation of a pneumatic tourniquet | Experimental | Not described Receives: Procedure: pneumatic tourniquet |
| No inflation | Sham comparator | No inflation of the pneumatic tourniquet placed on the lower limb Receives: Other: No inflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indocyanine green clearance
Indocyanine green clearance (%/min) by indocyanine green retention, measured with Limon pulse spectrophotometry method.
Measured: at 5 days after liver resection
Secondary outcomes (5)
Serum transaminases rates
Measured: at day 1,day 3 and day 5 post-hepatectomy.
Prothrombin rate
Measured: at day 5 post-hepatectomy.
the Kidney Disease: Improving Global Outcomes (KDIGO) score
The score varies from 1 to 4.
Measured: at day 1,day 3 and day 5 post-hepatectomy.
the Clavien & Dindo score
this classification in order to rank a post operative complications. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V)
Measured: at day 30 post-hepatectomy
duration of stay in the hospital.
Measured: at day 30 post-hepatectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start16 Jun 2019
- Primary completion6 Jan 2020
- Study completion6 Jan 2020
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Lebuffe, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181502
- Sponsor's protocol ID
- 2017_66
- Other IDs
- 2018-A03038-47
- Acronym
- HEPATOPROTECT
- Status last verified
- Oct 2022
- First submitted
- 20 Nov 2019
- Last updated
- 17 Oct 2022
- 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 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Single-blind Study of Remote Ischemic Preconditioning in Hepatectomies
- ClinicalTrials.gov ID
- NCT04181502
- Acronym / sponsor ID
- HEPATOPROTECT / 2017_66
- Conditions
- Liver Diseases
- Keywords
- Remote ischemic preconditioning, liver resection, liver clearance.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 16 Jun 2019 (actual)
- Primary completion
- 6 Jan 2020 (actual)
- Study completion
- 6 Jan 2020 (actual)
- First posted
- 29 Nov 2019 (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.
During hepatic transection, it exists a high risk of perioperative blood loss. The haemorrhage and its consequences (hypovolemia and blood transfusion) might impact the short and long term morbidity The vascular control by hepatic pedicle clamping (Pringle's maneuver) or total hepatic vascular exclusion, helps minimizing blood loss and leads to a more extensive hepatic resection.
Side effects of vascular control result of ischemia-reperfusion injury (IRI) : these reperfusion lesions results of different mechanisms than those responsible for the ischemic one. IRI cause lesions and postoperative dysfunction of the remaining liver.
Among strategies to reduce the adverse effects of IRI : ischaemic preconditioning (IPC) has been described. It can be either mechanical (intermittent hepatic pedicle clamping) or pharmacological (sevoflurane inhalation).
Short intermittent vascular occlusions in a organ might produce a resistance to a longer ischaemic period. It is certainly a physiological organ adaptation to tissue hypoxemia, which has a therapeutic potential when targeted.
During liver resection, ischaemic preconditioning is realised with periods of hepatic pedicle clamping and unclamping. It decrease morbidity and mortality and prevent postoperative hepatocellular insufficiency due to clamping and IRI at day 5.
Ischaemic preconditioning may also be applied remotely. Indeed, it is shown that short ischaemic periods in a target organ can also have a protective effect on distant others. This mechanism involve three signalling pathways : neuronal , humoral and systemic pathways.
In a previous randomized study, Kanoria and al, demonstrated that the remote ischaemic preconditioning group has shown significant lower rates of serum transaminases and higher liver clearance (spectrophotometry method) than the control group.
A latest study, measuring postoperative prothrombin rates has shown improved liver recovery due to halogen agents such as sevoflurane.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inflation of a pneumatic tourniquet | Experimental | Procedure: pneumatic tourniquet |
| No inflation | Sham comparator | Other: No inflationNo inflation of the pneumatic tourniquet placed on the lower limb |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled carcinogenic laparoscopy or laparotomy liver resection
- Insured under the social security system
- Inclined to comply to the study protocol and its duration.
Key exclusion criteria (9 listed)
- Patient under guardianship
- Pregnancy or breastfeeding
- Severe lower limb vascular disease
- Emergency surgery
- Contraindication of a treatment from the protocol
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 |
|---|---|---|
| pneumatic tourniqueta pneumatic tourniquet around 200 mmHg after venous chase of the lower limb, during 5 minutes then deflated. Repeated twice after general anaesthesia and prior to incision. | Procedure or surgery | Inflation of a pneumatic tourniquet |
| No inflationNo inflation of the pneumatic tourniquet placed on the lower limb | Other | No inflation |
Primary outcome
Indocyanine green clearance
Time frame: at 5 days after liver resection
Indocyanine green clearance (%/min) by indocyanine green retention, measured with Limon pulse spectrophotometry method.
5 secondary outcomes
Serum transaminases rates
Time frame: at day 1,day 3 and day 5 post-hepatectomy.
Prothrombin rate
Time frame: at day 5 post-hepatectomy.
the Kidney Disease: Improving Global Outcomes (KDIGO) score
Time frame: at day 1,day 3 and day 5 post-hepatectomy.
the Clavien & Dindo score
Time frame: at day 30 post-hepatectomy
duration of stay in the hospital.
Time frame: at day 30 post-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 17 Oct 2022.
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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.
Gilles Lebuffe, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pneumatic tourniquet and No inflation in people with Liver Diseases, run by University Hospital, Lille 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 9 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 17 Oct 2022. 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. Some participants in this study may receive a placebo. 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?
Indocyanine green clearance (time frame: at 5 days after liver resection). 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 17 Oct 2022.