Ischemic Preconditioning at a Distance in Liver Surgery

Not Applicable

Completed

• Conditions: Liver Diseases

• Registration Number: NCT04181502
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-16
• Study First Submitted: 2019-11-20
• Study First Submitted QC: 2019-11-27
• Study First Posted: 2019-11-29
• Primary Completion: 2020-01-06
• Study Completion: 2020-01-06
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-14
• Last Update Posted: 2022-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Indocyanine green clearance	at 5 days after liver resection	Indocyanine green clearance (%/min) by indocyanine green retention, measured with Limon pulse spectrophotometry method.

Secondary Outcome Measures

Name	Time	Method
Serum transaminases rates	at day 1,day 3 and day 5 post-hepatectomy.
Prothrombin rate	at day 5 post-hepatectomy.
duration of stay in the hospital.	at day 30 post-hepatectomy
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.
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)

Trial Locations

Locations (1)

Hop Claude Huriez Chu Lille; 🇫🇷 Lille, France