Clinical trial NCT04181502: Ischemic Preconditioning at a Distance in Liver Surgery
Official title: Randomized, Single-blind Study of Remote Ischemic Preconditioning in Hepatectomies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Diseases
Keywords: Remote ischemic preconditioning
liver resection
liver clearance.
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2019-11-29
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* Scheduled carcinogenic laparoscopy or laparotomy liver resection
* Insured under the social security system
* Inclined to comply to the study protocol and its duration.

Exclusion Criteria:

* 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
* Absence of written informed consent
* Refusal to sign the protocol
* Non-registration to the social security system

Primary outcomes:
measure: Indocyanine green clearance
timeFrame: at 5 days after liver resection
Secondary outcomes:
measure: Serum transaminases rates
timeFrame: at day 1,day 3 and day 5 post-hepatectomy.
measure: Prothrombin rate
timeFrame: at day 5 post-hepatectomy.
measure: the Kidney Disease: Improving Global Outcomes (KDIGO) score
timeFrame: at day 1,day 3 and day 5 post-hepatectomy.
measure: the Clavien & Dindo score
timeFrame: at day 30 post-hepatectomy
measure: duration of stay in the hospital.
timeFrame: at day 30 post-hepatectomy
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Gilles Lebuffe, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: