Ischemic Preconditioning at a Distance in Liver Surgery

NCT ID: NCT04181502

Last Updated: 2022-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-16
• Study Completion Date: 2020-01-06

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.

Conditions

Liver Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Inflation of a pneumatic tourniquet

Group Type: EXPERIMENTAL

pneumatic tourniquet

Intervention Type: PROCEDURE

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 inflation

No inflation of the pneumatic tourniquet placed on the lower limb

Group Type: SHAM_COMPARATOR

No inflation

Intervention Type: OTHER

No inflation of the pneumatic tourniquet placed on the lower limb

Interventions

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.

Intervention Type: PROCEDURE

No inflation

No inflation of the pneumatic tourniquet placed on the lower limb

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilles Lebuffe, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hop Claude Huriez Chu Lille

Lille, , France

Countries

France

Other Identifiers

2018-A03038-47

Identifier Type: OTHER

Identifier Source: secondary_id

2017_66

Identifier Type: -

Identifier Source: org_study_id