Ischemic Preconditioning at a Distance in Liver Surgery

Seuls les utilisateurs enregistrés peuvent traduire des articles

Se connecter S'inscrire

Le lien est enregistré dans le presse-papiers

StatutPas encore de recrutement

Les sponsors

University Hospital, Lille

ESSAI CLINIQUE: NCT04181502

BioSeek: nct04181502

Mots clés

Abstrait

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.

Rendez-vous

Dernière vérification:	10/31/2019
Première soumission:	11/19/2019
Inscription estimée soumise:	11/26/2019
Première publication:	11/28/2019
Dernière mise à jour soumise:	11/26/2019
Dernière mise à jour publiée:	11/28/2019
Date de début réelle de l'étude:	01/31/2020
Date d'achèvement primaire estimée:	01/31/2021
Date estimée d'achèvement de l'étude:	01/31/2021

Condition ou maladie

Liver Diseases

Intervention / traitement

Procedure: Inflation of a pneumatic tourniquet

Other: No inflation

Phase

Groupes d'armes

Bras	Intervention / traitement
Experimental: Inflation of a pneumatic tourniquet	Procedure: Inflation of a pneumatic tourniquet 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.
Sham Comparator: No inflation No inflation of the pneumatic tourniquet placed on the lower limb	Other: No inflation No inflation of the pneumatic tourniquet placed on the lower limb

Critère d'éligibilité

Âges éligibles aux études	18 Years À 18 Years
Sexes éligibles à l'étude	All
Accepte les bénévoles en santé	Oui
Critères	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

Résultat

Mesures des résultats primaires

1. Indocyanine green clearance [at 5 days after liver resection]

Indocyanine green clearance (%/min) by indocyanine green retention, measured with Limon pulse spectrophotometry method.

Mesures des résultats secondaires

1. Serum transaminases rates [at day 1,day 3 and day 5 post-hepatectomy.]

2. Prothrombin rate [at day 5 post-hepatectomy.]

3. the Kidney Disease: Improving Global Outcomes (KDIGO) score [at day 1,day 3 and day 5 post-hepatectomy.]

The score varies from 1 to 4.

4. the Clavien & Dindo score [at day 30 post-hepatectomy]

this classification in order to rank a post operative complications. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V)

5. duration of stay in the hospital. [at day 30 post-hepatectomy]

Ischemic Preconditioning at a Distance in Liver Surgery

Mots clés

hypoxie

hémorragie

hypovolémie

ischémie

antimycosique