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Ischemic Preconditioning at a Distance in Liver Surgery (HEPATOPROTECT)

Primary Purpose

Liver Diseases

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
pneumatic tourniquet
No inflation
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Liver Diseases focused on measuring Remote ischemic preconditioning, liver resection, liver clearance.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hop Claude Huriez Chu Lille

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Inflation of a pneumatic tourniquet

No inflation

Arm Description

No inflation of the pneumatic tourniquet placed on the lower limb

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Serum transaminases rates
Prothrombin rate
the Kidney Disease: Improving Global Outcomes (KDIGO) score
The score varies from 1 to 4.
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)
duration of stay in the hospital.

Full Information

First Posted
November 20, 2019
Last Updated
October 14, 2022
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT04181502
Brief Title
Ischemic Preconditioning at a Distance in Liver Surgery
Acronym
HEPATOPROTECT
Official Title
Randomized, Single-blind Study of Remote Ischemic Preconditioning in Hepatectomies
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 16, 2019 (Actual)
Primary Completion Date
January 6, 2020 (Actual)
Study Completion Date
January 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Diseases
Keywords
Remote ischemic preconditioning, liver resection, liver clearance.

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inflation of a pneumatic tourniquet
Arm Type
Experimental
Arm Title
No inflation
Arm Type
Sham Comparator
Arm Description
No inflation of the pneumatic tourniquet placed on the lower limb
Intervention Type
Procedure
Intervention Name(s)
pneumatic tourniquet
Intervention Description
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
Other
Intervention Name(s)
No inflation
Intervention Description
No inflation of the pneumatic tourniquet placed on the lower limb
Primary Outcome Measure Information:
Title
Indocyanine green clearance
Description
Indocyanine green clearance (%/min) by indocyanine green retention, measured with Limon pulse spectrophotometry method.
Time Frame
at 5 days after liver resection
Secondary Outcome Measure Information:
Title
Serum transaminases rates
Time Frame
at day 1,day 3 and day 5 post-hepatectomy.
Title
Prothrombin rate
Time Frame
at day 5 post-hepatectomy.
Title
the Kidney Disease: Improving Global Outcomes (KDIGO) score
Description
The score varies from 1 to 4.
Time Frame
at day 1,day 3 and day 5 post-hepatectomy.
Title
the Clavien & Dindo score
Description
this classification in order to rank a post operative complications. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V)
Time Frame
at day 30 post-hepatectomy
Title
duration of stay in the hospital.
Time Frame
at day 30 post-hepatectomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles Lebuffe, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hop Claude Huriez Chu Lille
City
Lille
ZIP/Postal Code
59037
Country
France

12. IPD Sharing Statement

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Ischemic Preconditioning at a Distance in Liver Surgery

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