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

About this trial
This is an interventional other trial for Liver Diseases focused on measuring Remote ischemic preconditioning, liver resection, liver clearance.
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
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
NCT ID
NCT04181502
First Posted
November 20, 2019
Last Updated
October 14, 2022
Sponsor
University Hospital, Lille
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
Learn more about this trial
Ischemic Preconditioning at a Distance in Liver Surgery
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