Ischemic Preconditioning at a Distance in Liver Surgery

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Patrocinadors

University Hospital, Lille

ASSAIG CLÍNIC: NCT04181502

BioSeek: nct04181502

Paraules clau

Resum

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.

Dates

Darrera verificació:	10/31/2019
Primer enviat:	11/19/2019
Inscripció estimada enviada:	11/26/2019
Publicat per primera vegada:	11/28/2019
Última actualització enviada:	11/26/2019
Publicació de l'última actualització:	11/28/2019
Data d'inici de l'estudi real:	01/31/2020
Data estimada de finalització primària:	01/31/2021
Data estimada de finalització de l’estudi:	01/31/2021

Condició o malaltia

Liver Diseases

Intervenció / tractament

Procedure: Inflation of a pneumatic tourniquet

Other: No inflation

Fase

Grups de braços

Braç	Intervenció / tractament
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

Criteris d'elegibilitat

Edats elegibles per estudiar	18 Years Per a 18 Years
Sexes elegibles per estudiar	All
Accepta voluntaris saludables	Sí
Criteris	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

Resultat

Mesures de resultats primaris

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 de resultats secundaris

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

Paraules clau

hypoxia

hemorràgia

hipovolèmia

isquèmia

antifúngic