Ischemic Preconditioning at a Distance in Liver Surgery

Liver Diseases Clinical Trial

— HEPATOPROTECT  

Official title:

Randomized, Single-blind Study of Remote Ischemic Preconditioning in Hepatectomies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04181502
• Other study ID #: 2017_66
• Secondary ID: 2018-A03038-47
• Status: Completed
• Phase: N/A
• Start date: June 16, 2019
• Est. completion date: January 6, 2020

Study information

• Verified date: October 2022
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 6, 2020
• Est. primary completion date: January 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Diseases

Intervention

Procedure:
• 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.

Other:
• No inflation
No inflation of the pneumatic tourniquet placed on the lower limb

Locations

Country	Name	City	State
France	Hop Claude Huriez Chu Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Indocyanine green clearance	Indocyanine green clearance (%/min) by indocyanine green retention, measured with Limon pulse spectrophotometry method.	at 5 days after liver resection
Secondary	Serum transaminases rates		at day 1,day 3 and day 5 post-hepatectomy.
Secondary	Prothrombin rate		at day 5 post-hepatectomy.
Secondary	the Kidney Disease: Improving Global Outcomes (KDIGO) score	The score varies from 1 to 4.	at day 1,day 3 and day 5 post-hepatectomy.
Secondary	the Clavien & Dindo score	this classification in order to rank a post operative complications. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V)	at day 30 post-hepatectomy
Secondary	duration of stay in the hospital.		at day 30 post-hepatectomy