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OpenTrials
Completed

NCT Number: NCT04181502

Ischemic Preconditioning at a Distance in Liver Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hop Claude Huriez Chu Lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

No inflation

Other

No inflation of the pneumatic tourniquet placed on the lower limb

Primary outcomes

  1. Indocyanine green clearance

    Time frame: at 5 days after liver resection

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

Secondary outcomes

  1. Serum transaminases rates

    Time frame: at day 1,day 3 and day 5 post-hepatectomy.

  2. Prothrombin rate

    Time frame: at day 5 post-hepatectomy.

  3. the Kidney Disease: Improving Global Outcomes (KDIGO) score

    Time frame: at day 1,day 3 and day 5 post-hepatectomy.

    The score varies from 1 to 4.

  4. the Clavien & Dindo score

    Time frame: 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.

    Time frame: at day 30 post-hepatectomy

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: HEPATOPROTECT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 29, 2019
Registry last updated
Oct 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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