Ischemic Preconditioning at a Distance in Liver Surgery

NCT04181502 | Completed

• 2 other identifiers: 2017_662018-A03038-47
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Keywords

Remote ischemic preconditioning; liver resection; liver clearance.

Outcome Measures

Primary Outcomes (1)

• Indocyanine green clearance

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

  at 5 days after liver resection

Secondary Outcomes (5)

• Serum transaminases rates

  at day 1,day 3 and day 5 post-hepatectomy.

• Prothrombin rate

  at day 5 post-hepatectomy.

• the Kidney Disease: Improving Global Outcomes (KDIGO) score

  at day 1,day 3 and day 5 post-hepatectomy.

• the Clavien & Dindo score

  at day 30 post-hepatectomy

• duration of stay in the hospital.

  at day 30 post-hepatectomy

Study Arms (2)

Inflation of a pneumatic tourniquet

EXPERIMENTAL

Procedure: pneumatic tourniquet

No inflation

SHAM COMPARATOR

No inflation of the pneumatic tourniquet placed on the lower limb

Other: No inflation

Interventions

pneumatic tourniquet 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.

Inflation of a pneumatic tourniquet

No inflation OTHER

No inflation of the pneumatic tourniquet placed on the lower limb

No inflation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled carcinogenic laparoscopy or laparotomy liver resection
• Insured under the social security system
• Inclined to comply to the study protocol and its duration.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Claude Huriez Chu Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Gilles Lebuffe, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 29, 2019
• Study Start: June 16, 2019
• Primary Completion: January 6, 2020
• Study Completion: January 6, 2020
• Last Updated: October 17, 2022

Record last verified: 2022-10

Locations

FR (1)